Fresh Recalls

FDA recalls — page 5

2,784 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing 1,201–1,500, newest first.

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Solo Precision IV Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Company / brand: ICU Medical recalls

Official ID Z-2724-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Duo Infusion Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Company / brand: ICU Medical recalls

Official ID Z-2723-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

da Vinci SP Instrument Arm Drape recall — Intuitive Surgical, Inc.

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a secti…

Company / brand: Intuitive Surgical recalls

Official ID Z-2722-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Glass Body for 194 Ellik Evacuator recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Official ID Z-2721-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Ellik Evacuator Includes Glass Body recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Official ID Z-2720-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 50cc with Adaptor recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Official ID Z-2719-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 30cc with Adaptor recall — Olympus Corporation of the Americas

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Company / brand: Olympus of the Americas recalls

Official ID Z-2718-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Bone Marrow Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2709-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Arterial Line Kit 20ga x 6 recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2708-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

T-Lok Bone Marrow Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2707-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

General Biospy Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2706-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

One-Piece Introducer Tray recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2705-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall — Argon Medical Devices, Inc

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Company / brand: Argon Medical Devices recalls

Official ID Z-2704-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Intro Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2693-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Insertion Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2692-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2691-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Smart Assist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2690-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2689-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2688-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2687-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2686-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2685-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Introducer Kit 23 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2684-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2683-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2682-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella RP Flex with SmartAssist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Official ID Z-2681-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Official ID Z-2680-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Official ID Z-2679-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

Abiomed REF recall — Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub …

Company / brand: Oscor recalls

Official ID Z-2678-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Organic Whole Blueberries recall — Frutas y Hortalizas del Sur S.A.

Potential E. coli O145:H28 Contamination

Company / brand: Frutas y Hortalizas del Sur recalls

Official ID H-1181-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

Ruby recall — GELLERT GLOBAL GROUP

Foreign material (Glass) was found in the product.

Company / brand: GELLERT GLOBAL GROUP recalls

Official ID H-1176-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT recall — Fayus Inc.

Undeclared peanuts

Company / brand: Fayus recalls

Official ID H-1175-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT recall — AMY'S KITCHEN INC.

Potential for spoilage.

Company / brand: AMY'S KITCHEN recalls

Official ID H-1174-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1173-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1172-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1171-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1170-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1169-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1168-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1167-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1166-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1165-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1164-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1163-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1162-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1161-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1160-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1159-2026 · Official record ↗

FDA Class I · Food · July 22, 2026

Ice Pop recall — D'Dioses Fruit Pops, Inc.

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

Company / brand: D'Dioses Fruit Pops recalls

Official ID H-1158-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

WY Duck Sauce recall — W.Y. Industries, Inc.

Product may contain metal fragments.

Company / brand: W.Y. Industries recalls

Official ID H-1157-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

Winfield's CWB Chocolate Bar recall — Chocolate Bar Holdings LLC

Undeclared milk allergen.

Company / brand: Chocolate Bar Holdings recalls

Official ID H-1156-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

Pillsbury Bread Rolls recall — General Mills James Ford Bell Technical Center

Potential foreign material (glass)

Company / brand: General Mills James Ford Bell Technical Center recalls

Official ID H-1155-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

Pillsbury Bread Rolls recall — General Mills James Ford Bell Technical Center

Potential foreign material (glass)

Company / brand: General Mills James Ford Bell Technical Center recalls

Official ID H-1154-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY recall — Nutricia North America

Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A…

Company / brand: Nutricia North America recalls

Official ID H-1153-2026 · Official record ↗

FDA Class II · Food · July 22, 2026

functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BE recall — Nutricia North America

Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A…

Company / brand: Nutricia North America recalls

Official ID H-1152-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Company / brand: CareFusion 213 recalls

Official ID D-0690-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0 recall — Chiesi USA, Inc.

Lack of Assurance of Sterility

Company / brand: Chiesi USA recalls

Official ID D-0689-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CAREone recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0688-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

meijer recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0687-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Foster & Thrive recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0686-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

LEADER recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0685-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

GOOD NEIGHBOR PHARMACY recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0684-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

FAMILY Wellness recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0683-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

AUDIOLOGIST'S CHOICE recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0682-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

TopCare Health recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0681-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

QC Quality Choice recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0680-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Clinere recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0679-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CVS Health recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Official ID D-0678-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Nystatin Cream USP recall — Padagis US LLC

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Company / brand: Padagis US recalls

Official ID D-0677-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — CMR SURGICAL LIMITED

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Company / brand: CMR SURGICAL recalls

Official ID Z-2717-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

TMINI Femur Tracking Array REF 109003 UDI-DI code recall — Think Surgical, Inc.

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

Company / brand: Think Surgical recalls

Official ID Z-2716-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

VITEK 2 AST-N447 TEST KIT Product reference 424620 recall — Biomerieux Inc

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Company / brand: Biomerieux recalls

Official ID Z-2715-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

OmniTract Surgical Retractor System recall — Integra LifeSciences Corp. (NeuroSciences)

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 …

Company / brand: Integra LifeSciences (NeuroSciences) recalls

Official ID Z-2714-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

GSP Neonatal GALT Kit recall — WALLAC OY

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

Company / brand: WALLAC OY recalls

Official ID Z-2713-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Official ID Z-2712-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Official ID Z-2711-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Company / brand: Elekta recalls

Official ID Z-2710-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patien…

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-2703-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

5008X Blood Tubing Set recall — Fresenius Medical Care Holdings, Inc.

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Company / brand: Fresenius Medical Care Holdings recalls

Official ID Z-2702-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Encore Medical, LP

Due to packaging discrepancy with incorrect product size mixed up.

Company / brand: Encore Medical recalls

Official ID Z-2701-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Brand Name recall — Encore Medical, LP

Due to packaging discrepancy with incorrect product size mixed up.

Company / brand: Encore Medical recalls

Official ID Z-2700-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

KL Owen Custom Orthodontic Solution recall — Klowen Braces

A product error defect may cause incorrect bracket placement.

Company / brand: Klowen Braces recalls

Official ID Z-2699-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

MiniMed 780G Insulin Pump recall — Medtronic MiniMed, Inc.

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error me…

Company / brand: Medtronic MiniMed recalls

Official ID Z-2698-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Official ID Z-2697-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Official ID Z-2696-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Medline Convenience Kits recall — Medline Industries, LP

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…

Company / brand: Medline Industries recalls

Official ID Z-2695-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Intracept Access Instruments recall — Boston Scientific Neuromodulation Corporation

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to…

Company / brand: Boston Scientific Neuromodulation recalls

Official ID Z-2694-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Aquacel Ag Surgical SP REF recall — ConvaTec, Inc

Surgical dressing manufactured out of specification (greater thickness).

Company / brand: ConvaTec recalls

Official ID Z-2677-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Olympus Single Use Distal Cover recall — Olympus Corporation of the Americas

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Company / brand: Olympus of the Americas recalls

Official ID Z-2676-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

High Valley Orchard Chocolate Covered Raisins recall — Lehi Valley Trading Company, Inc

Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.

Company / brand: Lehi Valley Trading Company recalls

Official ID H-1150-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

Fresh to You Burger Chicken Fillet recall — Fresh & Ready Foods LLC

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the pote…

Company / brand: Fresh & Ready Foods recalls

Official ID H-1149-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

Fresh to You Burger Chicken Fillet Deluxe with Bacon recall — Fresh & Ready Foods LLC

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due …

Company / brand: Fresh & Ready Foods recalls

Official ID H-1148-2026 · Official record ↗

FDA Class II · Food · July 15, 2026

Alabama Banana Pudding Marshmallow recall — Wondermade LLC

Foreign material: small metal pieces

Company / brand: Wondermade recalls

Official ID H-1147-2026 · Official record ↗

FDA Class II · Food · July 15, 2026

Wise Onion Rings recall — Wise Foods Inc

The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.

Company / brand: Wise Foods recalls

Official ID H-1146-2026 · Official record ↗

FDA Class II · Food · July 15, 2026

Vanilla Dessert Shells (Giant) recall — Specialty Bakers, LLC

Undeclared Allergen (Soy)

Company / brand: Specialty Bakers recalls

Official ID H-1145-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

Trafa Pharmaceuticals Inc recall — Trafa Pharmaceutical Inc.

Potential contamination with Salmonella

Company / brand: Trafa Pharmaceutical recalls

Official ID H-1144-2026 · Official record ↗

FDA Class II · Food · July 15, 2026

Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough recall — Bear Stewart Co

undeclared soy

Company / brand: Bear Stewart Co recalls

Official ID H-1143-2026 · Official record ↗

FDA Class II · Food · July 15, 2026

Johnny's Salad and Pasta Elegance 5 recall — Adams Extract & Spice LLC

Undeclared Sesame allergen

Company / brand: Adams Extract & Spice recalls

Official ID H-1142-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

Coopers Bbq 60 Gal Bean Mix box recall — Adams Extract & Spice LLC

Undeclared Sesame allergen

Company / brand: Adams Extract & Spice recalls

Official ID H-1141-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

EC Hot Links Seasoning 45 recall — Adams Extract & Spice LLC

Undeclared Sesame allergen

Company / brand: Adams Extract & Spice recalls

Official ID H-1140-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

JB Chicken Sknls 35 recall — Adams Extract & Spice LLC

Undeclared Sesame allergen

Company / brand: Adams Extract & Spice recalls

Official ID H-1139-2026 · Official record ↗

FDA Class I · Food · July 15, 2026

Smoked Sausage Spice 32 recall — Adams Extract & Spice LLC

Undeclared Sesame allergen

Company / brand: Adams Extract & Spice recalls

Official ID H-1138-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS recall — Shimoga Chemicals

cGMP deviations

Company / brand: Shimoga Chemicals recalls

Official ID D-0691-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Azacitidine for Injection 100mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Official ID D-0674-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Bortezomib for Injection 3 recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Official ID D-0673-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Pemetrexed for Injection 500mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Official ID D-0672-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Pemetrexed for Injection 100mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Official ID D-0671-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0670-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0669-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0668-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0667-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0666-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Official ID D-0665-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Methohexital Sodium recall — QuVa Pharma, Inc.

Failed Impurities/Degradation Specifications

Company / brand: QuVa Pharma recalls

Official ID D-0664-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall — BioMed Laboratories, LLC.

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Company / brand: BioMed Laboratories recalls

Official ID D-0663-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Methohexital Sodium for Injection recall — ONESOURCE SPECIALTY PHARMA LIMITED

Failed Impurities/Degradation Specifications

Company / brand: ONESOURCE SPECIALTY PHARMA recalls

Official ID D-0662-2026 · Official record ↗

FDA Not Yet Classified · Drug · July 8, 2026

Glucagon Emergency Kit for Low Blood Sugar recall — Lupin Pharmaceuticals Inc.

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Company / brand: Lupin Pharmaceuticals recalls

Official ID EVT-99296-c9qbin · Official record ↗

FDA Class II · Food · July 8, 2026

Le Chef Bakery branded Mini Italian Pastry Assortment recall — Le Chef Bakery

undeclared colors (yellow#5)

Company / brand: Le Chef Bakery recalls

Official ID EVT-99205-115w1r1 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…

Company / brand: Zimmer Surgical recalls

Official ID Z-2674-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni…

Company / brand: Zimmer Surgical recalls

Official ID Z-2673-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region recall — W L Gore & Associates, Inc.

Due to catheter separation

Company / brand: W L Gore & Associates recalls

Official ID Z-2672-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Radius VSM Disposable NIBP Cuff recall — Masimo Corporation

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…

Company / brand: Masimo recalls

Official ID Z-2671-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Radius VSM ECG pre-connected Set recall — Masimo Corporation

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…

Company / brand: Masimo recalls

Official ID Z-2670-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Solar GI System (Water Perfusion) recall — Laborie Medical Technologies Corp

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the h…

Company / brand: Laborie Medical Technologies recalls

Official ID Z-2669-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2668-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2667-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2666-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2665-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2664-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2663-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2662-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2661-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Co recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2660-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2659-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2658-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2657-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2656-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

OTP5000 THORA/PARA TRAY recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Official ID Z-2655-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number recall — BD SWITZERLAND SARL

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

Company / brand: BD SWITZERLAND SARL recalls

Official ID Z-2654-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall — Covidien LLC

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Company / brand: Covidien recalls

Official ID Z-2653-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Zeiss Intrabeam Spherical Applicator 1 recall — Carl Zeiss Meditec AG

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Company / brand: Carl Zeiss Meditec AG recalls

Official ID Z-2649-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradual…

Company / brand: Siemens Medical Solutions USA recalls

Official ID Z-2648-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

RayCare 2024A SP4 recall — RAYSEARCH LABORATORIES AB

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…

Company / brand: RAYSEARCH LABORATORIES AB recalls

Official ID Z-2647-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

RayCare 2024A SP1 recall — RAYSEARCH LABORATORIES AB

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…

Company / brand: RAYSEARCH LABORATORIES AB recalls

Official ID Z-2646-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Medela Inc

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritiona…

Company / brand: Medela recalls

Official ID Z-2645-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…

Company / brand: Accuray Incorporated recalls

Official ID Z-2644-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono floor recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Official ID Z-2643-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Official ID Z-2642-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono biplane recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Official ID Z-2641-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…

Company / brand: Accuray Incorporated recalls

Official ID Z-2640-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — TELEFLEX LLC

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Company / brand: TELEFLEX recalls

Official ID Z-2639-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Adapter for Head Positioning recall — Baxter Healthcare Corporation

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Secti…

Company / brand: Baxter Healthcare recalls

Official ID Z-2638-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 18-20mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2637-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 15-18mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2636-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 12-15mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2635-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 10-12mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2634-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 8-10mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2633-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 6-8mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2632-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 18-20mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2631-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 15-18mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2630-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 12-15mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2629-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 10-12mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2628-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 8-10mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2627-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 6-8mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Official ID Z-2626-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

IntelliCuff recall — Hamilton Medical AG

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by…

Company / brand: Hamilton Medical AG recalls

Official ID Z-2625-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves Division

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedur…

Company / brand: Medtronic Heart Valves Division recalls

Official ID Z-2624-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

GC Agar Base (150mm) 10/PK R04030 recall — Remel, Inc

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Company / brand: Remel recalls

Official ID Z-2623-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-2622-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-2621-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-2620-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Official ID Z-2619-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Short Monobloc Stem Broaches recall — Medacta Usa Inc

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are posit…

Company / brand: Medacta Usa recalls

Official ID Z-2618-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-2617-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Official ID Z-2616-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall — Medline Industries, LP

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface…

Company / brand: Medline Industries recalls

Official ID Z-2615-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

SYRINGE LUER LOK 10CC-200/BOX BD Product Code recall — Mentor Texas LP

A single lot of expired syringes were distributed due to a distribution system control failure.

Company / brand: Mentor Texas LP recalls

Official ID Z-2614-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2613-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2612-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2611-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2610-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ9 recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2609-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2608-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2607-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Official ID Z-2606-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod (Eros) Pod recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Official ID Z-2605-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod DASH Pod recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Official ID Z-2604-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod 5 Pods recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Official ID Z-2603-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Official ID Z-2551-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Official ID Z-2550-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Official ID Z-2549-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Official ID Z-2548-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2547-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2546-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2545-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2544-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2543-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2542-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2541-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2540-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2539-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2538-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2537-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2536-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2535-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2534-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Official ID Z-2533-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Breathing circuit set recall — Hamilton Medical AG

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalati…

Company / brand: Hamilton Medical AG recalls

Official ID Z-2463-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH recall — Wells Enterprises, Inc.

Elevated coliforms

Company / brand: Wells Enterprises recalls

Official ID H-1151-2026 · Official record ↗

FDA Class I · Food · July 8, 2026

a recall — NARA ORGANICS INC

Product may be contaminated with Clostridium botulinum.

Company / brand: NARA ORGANICS recalls

Official ID H-1137-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

Pepperoni Rolls recall — Fry Pie Factory LLC

Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)

Company / brand: Fry Pie Factory recalls

Official ID H-1136-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

Vista MAX recall — Provision Health Corp. dba PH Labs

Dietary supplement product Vista MAX contains undeclared Yellow#5.

Company / brand: Provision Health dba PH Labs recalls

Official ID H-1135-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

Ocular Plus with Lutein recall — Provision Health Corp. dba PH Labs

Dietary supplement product Ocular Plus contains undeclared Yellow#5.

Company / brand: Provision Health dba PH Labs recalls

Official ID H-1134-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

MorningStar Farms Hot & Spicy Sausage Patties recall — MARS SNACKING

Potential contamination with plastic material

Company / brand: MARS SNACKING recalls

Official ID H-1130-2026 · Official record ↗

FDA Class II · Food · July 8, 2026

MorningStar Farms Buffalo Chik'n Nuggets recall — MARS SNACKING

Potential contamination with plastic material

Company / brand: MARS SNACKING recalls

Official ID H-1129-2026 · Official record ↗

FDA Class I · Food · July 8, 2026

MOGO PURE MORINGA OLEIFERA CAPSULES recall — MOGO Moringa LLC

Product may be contaminated with Salmonella Typhimurium

Company / brand: MOGO Moringa recalls

Official ID H-1128-2026 · Official record ↗

FDA Class I · Food · July 8, 2026

FIRST STREET Dark Chocolate Raisins Net Wt recall — Western Mixers Produce & Nuts, Inc.

Undeclared peanuts.

Company / brand: Western Mixers Produce & Nuts recalls

Official ID H-1125-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Glucagon Emergency Kit for Low Blood Sugar recall — Lupin Pharmaceuticals Inc.

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Company / brand: Lupin Pharmaceuticals recalls

Official ID D-0723-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Gemcitabine Injection recall — McKesson

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Company / brand: McKesson recalls

Official ID D-0714-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Revitaderm Wound Care recall — Blaine Labs Inc

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Company / brand: Blaine Labs recalls

Official ID D-0699-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Fungal Fusion ERADICATION Solution recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Official ID D-0698-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TERPENICOL Antifungal Solution recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Official ID D-0697-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

vite20 Antifungal Cream recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Official ID D-0696-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Official ID D-0695-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Official ID D-0694-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel recall — Blaine Labs Inc

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

Company / brand: Blaine Labs recalls

Official ID D-0693-2026 · Official record ↗

FDA Class I · Drug · July 8, 2026

Revitaderm Wound Care Gel recall — Blaine Labs Inc

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Company / brand: Blaine Labs recalls

Official ID D-0692-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Official ID D-0676-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Official ID D-0675-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Official ID D-0661-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Dextroamphetamine Saccharate recall — Lannett Company Inc.

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Company / brand: Lannett Company recalls

Official ID D-0660-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Lidocaine HCl Injection USP recall — Asclemed USA Inc.

Lack of Assurance of Sterility

Company / brand: Asclemed USA recalls

Official ID D-0659-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Accucaine recall — Asclemed USA Inc.

Lack of Assurance of Sterility

Company / brand: Asclemed USA recalls

Official ID D-0658-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall — Boehringer Ingelheim Pharmaceuticals, Inc.

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Company / brand: Boehringer Ingelheim Pharmaceuticals recalls

Official ID D-0657-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0656-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

prednisoLONE Acetate Ophthalmic Suspension recall — Lupin Pharmaceuticals Inc.

Presence of Foreign Substance

Company / brand: Lupin Pharmaceuticals recalls

Official ID D-0655-2026 · Official record ↗

FDA Class III · Drug · July 8, 2026

Fexofenadine Hydrochloride Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Official ID D-0654-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

IMULDOSA recall — ACCORD BIOPHARMA INC

Lack of assurance of Sterility:

Company / brand: ACCORD BIOPHARMA recalls

Official ID D-0653-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0652-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0651-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0650-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0649-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0648-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0647-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

ChloraPrep FREPP recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0646-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0645-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0644-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Official ID D-0643-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Official ID Z-2602-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Official ID Z-2601-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Official ID Z-2600-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Official ID Z-2599-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2596-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2595-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2594-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2593-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2592-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2591-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2590-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2589-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2588-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2587-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2586-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2585-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2584-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2583-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2582-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Official ID Z-2581-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall — Boston Scientific Corporation

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Company / brand: Boston Scientific recalls

Official ID Z-2580-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Telemetry Monitor 5500 1 recall — Philips North America Llc

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI…

Company / brand: Philips North America recalls

Official ID Z-2579-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Brand Name recall — Zimmer, Inc.

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

Company / brand: Zimmer recalls

Official ID Z-2578-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus 4 Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Official ID Z-2577-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus Evolution AS Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Official ID Z-2576-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus Evolution Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Official ID Z-2575-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Brand Name recall — Dexcom, Inc.

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies …

Company / brand: Dexcom recalls

Official ID Z-2574-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2573-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2572-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2571-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2570-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2569-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2568-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2567-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2566-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2565-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2564-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2563-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2562-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2561-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2560-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2559-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2558-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2557-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2556-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Official ID Z-2555-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Thuvera Laser Console recall — IPG Medical Corporation

Software anomaly that causes a false display of error code 5018.

Company / brand: IPG Medical recalls

Official ID Z-2554-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

GE Healthcare AW Server 3 recall — GE Medical Systems SCS

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches…

Company / brand: GE Medical Systems SCS recalls

Official ID Z-2553-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

INZONE DETACHMENT SYSTEM recall — Stryker Neurovascular

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be …

Company / brand: Stryker Neurovascular recalls

Official ID Z-2552-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Acumed Hexalob Screw various sizes recall — Acumed LLC

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Company / brand: Acumed recalls

Official ID Z-2532-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Alliance Glenoid recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Official ID Z-2531-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Alliance Glenoid recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Official ID Z-2530-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Comprehensive Shoulder System recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Official ID Z-2529-2026 · Official record ↗

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FDA last checked October 22, 2026 at 12:00 PM UTC.