Fresh Recalls

FDA recalls — page 3

2,784 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing 601–900, newest first.

FDA Class III · Food · September 9, 2026

Wonton Specialist Inc recall — Wonton Specialists

Undeclared FD&C Red No. 40

Company / brand: Wonton Specialists recalls

Official ID H-1320-2026 · Official record ↗

FDA Class I · Food · September 9, 2026

Organic Cheddar Type Seasoning recall — Savor Seasonings LLC

Product tested positive for undeclared milk allergen.

Company / brand: Savor Seasonings recalls

Official ID H-1319-2026 · Official record ↗

FDA Class I · Food · September 9, 2026

THE HAMPTON GROCER brand recall — THE HAMPTON GROCER

Product may be contaminated with Salmonella.

Company / brand: THE HAMPTON GROCER recalls

Official ID H-1309-2026 · Official record ↗

FDA Class II · Food · September 9, 2026

Weis (Fresh From the Orchard ) Pasteurized Apple Cider recall — WEIS MARKETS, INC.

Product has high patulin levels

Company / brand: WEIS MARKETS recalls

Official ID H-1308-2026 · Official record ↗

FDA Class II · Food · September 9, 2026

Prince PAN DE MANTECA recall — Prince Bakery Inc

Milk is not declared in the Contains statement.

Company / brand: Prince Bakery recalls

Official ID H-1307-2026 · Official record ↗

FDA Class III · Food · September 9, 2026

Prince Sesame FRENCH BREAD recall — Prince Bakery Inc

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Company / brand: Prince Bakery recalls

Official ID H-1306-2026 · Official record ↗

FDA Class III · Food · September 9, 2026

Prince ITALIAN BREAD recall — Prince Bakery Inc

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Company / brand: Prince Bakery recalls

Official ID H-1305-2026 · Official record ↗

FDA Class III · Food · September 9, 2026

Prince ITALIAN BREAD recall — Prince Bakery Inc

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Company / brand: Prince Bakery recalls

Official ID H-1304-2026 · Official record ↗

FDA Class I · Food · September 9, 2026

Item #DIPSAU0205RFS Salsa Autentica 5 lb recall — Ron's Home Style Foods, Inc.

Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella

Company / brand: Ron's Home Style Foods recalls

Official ID H-1303-2026 · Official record ↗

FDA Class I · Food · September 9, 2026

Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic container recall — Ron's Home Style Foods, Inc.

Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella

Company / brand: Ron's Home Style Foods recalls

Official ID H-1302-2026 · Official record ↗

FDA Class I · Drug · September 9, 2026

Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACY

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Company / brand: OPTIMAL BALANCE PHARMACY recalls

Official ID D-0851-2026 · Official record ↗

FDA Class I · Drug · September 9, 2026

0 recall — Baxter Healthcare Corporation

Presence of particulate matter: Particulates identified as fiberglass

Company / brand: Baxter Healthcare recalls

Official ID D-0849-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Prasugrel HCI recall — Golden State Medical Supply Inc.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Company / brand: Golden State Medical Supply recalls

Official ID D-0847-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Buprenorphine Sublingual Tablets (C-III) recall — American Health Packaging

Labeling: Label Mix-up

Company / brand: American Health Packaging recalls

Official ID D-0840-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Prasugrel Tablets recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Company / brand: Mylan Pharmaceuticals recalls

Official ID D-0839-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Revcovi (elapegademase-lvlr) Injection recall — Chiesi USA, Inc.

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Company / brand: Chiesi USA recalls

Official ID D-0838-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

2% Chlorhexidine Gluconate* Cloth recall — Sage Products, LLC

Cross Contamination with Other Products

Company / brand: Sage Products recalls

Official ID D-0837-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

traZODone Hydrochloride Tablets recall — Teva Pharmaceuticals USA, Inc

Presence of Foreign Tablets/Capsules

Company / brand: Teva Pharmaceuticals USA recalls

Official ID D-0834-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Trokendi XR recall — Supernus Pharmaceuticals, Inc.

Failed dissolution specifications.

Company / brand: Supernus Pharmaceuticals recalls

Official ID D-0833-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Carton label recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

Company / brand: Mylan Pharmaceuticals recalls

Official ID D-0830-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Broadway Joe's Pain Cream recall — Lexia LLC

CGMP Deviations: Potential contamination of raw material

Company / brand: Lexia recalls

Official ID D-0829-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Broadway Joe's Pain Cream recall — Lexia LLC

CGMP Deviations: Potential contamination of raw material

Company / brand: Lexia recalls

Official ID D-0828-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Official ID D-0826-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Official ID D-0825-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Official ID D-0824-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Official ID D-0823-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recall — Bionpharma Inc.

Presence of Foreign Tablets/Capsules

Company / brand: Bionpharma recalls

Official ID D-0822-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Daptomycin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0821-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vancomycin Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0820-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vasopressin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0819-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0818-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0817-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Phosphate in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0816-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0815-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Nexterone (amiodarone HCI) recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0814-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

CARDENE IV (Nicardipine Hydrochloride) in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0813-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Pantoprazole Sodium in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0812-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vasopressin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0811-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Dexmedetomidine Hydrochloride in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0810-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Famotidine Injection in Sodium Chloride Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0809-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0808-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Daptomycin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0807-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

MYXREDLIN recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0806-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vancomycin Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Official ID D-0805-2026 · Official record ↗

FDA Not Yet Classified · Drug · September 2, 2026

Ibuprofen recall — Safecor Health, LLC

Cross Contamination with Other Products

Company / brand: Safecor Health recalls

Official ID EVT-99666-wagogx · Official record ↗

FDA Not Yet Classified · Food · September 2, 2026

Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICA recall — Africando Foods LLC

Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list

Company / brand: Africando Foods recalls

Official ID EVT-99642-1ffccqp · Official record ↗

FDA Class II · Medical device · September 2, 2026

FRU (Field replaceable unit) recall — GE Medical Systems Information Technologies Inc

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…

Company / brand: GE Medical Systems Information Technologies recalls

Official ID Z-3039-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

PORTRAIT CORE SERVICES SOFTWARE V1 recall — GE Medical Systems Information Technologies Inc

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…

Company / brand: GE Medical Systems Information Technologies recalls

Official ID Z-3038-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

PORTRAIT COMPUTE AND CORE SERVICES V1 recall — GE Medical Systems Information Technologies Inc

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…

Company / brand: GE Medical Systems Information Technologies recalls

Official ID Z-3037-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

PORTRAIT CORE SERVICES SOFTWARE V1 recall — GE Medical Systems Information Technologies Inc

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…

Company / brand: GE Medical Systems Information Technologies recalls

Official ID Z-3036-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

POWERSEAL 5 MM (in diameter) 23 CM (long) recall — Olympus Corporation of the Americas

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Company / brand: Olympus of the Americas recalls

Official ID Z-3035-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

ORT300 recall — IMRIS Imaging Inc

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This…

Company / brand: IMRIS Imaging recalls

Official ID Z-3034-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

ORT200 recall — IMRIS Imaging Inc

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This…

Company / brand: IMRIS Imaging recalls

Official ID Z-3033-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

healthmark ProChek-W Protein Test for Robotic Arms recall — Healthmark Industries Co., Inc.

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Company / brand: Healthmark Industries Co recalls

Official ID Z-3032-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

healthmark ProChek-II recall — Healthmark Industries Co., Inc.

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Company / brand: Healthmark Industries Co recalls

Official ID Z-3031-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

FUJIFILM Synapse PACS software v7 recall — FUJIFILM Healthcare Americas Corporation

Software issue may cause the ruler measurement to be inaccurate.

Company / brand: FUJIFILM Healthcare Americas recalls

Official ID Z-3030-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3029-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3028-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3027-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3026-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3025-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3024-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3023-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3022-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3021-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3020-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline convenience kits labeled as recall — Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

Company / brand: Medline Industries recalls

Official ID Z-3019-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5 recall — ConMed Corporation

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Company / brand: ConMed recalls

Official ID Z-3018-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Fresenius Medical Care recall — Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis m…

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Official ID Z-3017-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Grandio Universal Nano-Hybrid Restorative Material - Capsules 0 recall — Henry Schein Inc.

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Company / brand: Henry Schein recalls

Official ID Z-3016-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall — Henry Schein Inc.

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Company / brand: Henry Schein recalls

Official ID Z-3015-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluo recall — Canon Medical System, USA, INC.

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

Company / brand: Canon Medical System recalls

Official ID Z-3014-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Midmark Digital ECG HD+12 recall — Midmark Corporation

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Company / brand: Midmark recalls

Official ID Z-3013-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Midmark IQecg Digital ECG recall — Midmark Corporation

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Company / brand: Midmark recalls

Official ID Z-3012-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3011-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3010-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3009-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3008-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3007-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3006-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Brand Name recall — AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Company / brand: AVID Medical recalls

Official ID Z-3005-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Merge PACS and Merge OrthoPACS recall — Merge Healthcare, Inc.

Software issue may cause measurements to be displayed inaccurately.

Company / brand: Merge Healthcare recalls

Official ID Z-3004-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

American Contract System Convenience Kit recall — American Contract Systems Inc

The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…

Company / brand: American Contract Systems recalls

Official ID Z-3003-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

American Contract System Convenience Kits recall — American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…

Company / brand: American Contract Systems recalls

Official ID Z-3002-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

American Contract System Convenience Kit recall — American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…

Company / brand: American Contract Systems recalls

Official ID Z-3001-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

American Contract System Convenience Kit recall — American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…

Company / brand: American Contract Systems recalls

Official ID Z-3000-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline medical convenience kit labeled as recall — Medline Industries, LP

Component labeling discrepancy

Company / brand: Medline Industries recalls

Official ID Z-2999-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Onli 17cm Hydrophilic Urethral Intermittent Catheter recall — Hollister Ulc

Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary…

Company / brand: Hollister Ulc recalls

Official ID Z-2998-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline medical convenience kits recall — Medline Industries, LP

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…

Company / brand: Medline Industries recalls

Official ID Z-2997-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline medical convenience kits recall — Medline Industries, LP

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…

Company / brand: Medline Industries recalls

Official ID Z-2996-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline medical convenience kits recall — Medline Industries, LP

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…

Company / brand: Medline Industries recalls

Official ID Z-2995-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline medical convenience kits recall — Medline Industries, LP

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…

Company / brand: Medline Industries recalls

Official ID Z-2994-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline breathing circuits labeled as recall — Medline Industries, LP

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…

Company / brand: Medline Industries recalls

Official ID Z-2993-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline breathing circuits labeled as recall — Medline Industries, LP

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…

Company / brand: Medline Industries recalls

Official ID Z-2992-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Medline Hudson RCI recall — Medline Industries, LP

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…

Company / brand: Medline Industries recalls

Official ID Z-2991-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

Philips Incisive CT with software V4 recall — Philips Healthcare (Suzhou) Co., Ltd.

Potential of failing to trigger clinical scan during Bolus Tracking.

Company / brand: Philips Healthcare (Suzhou) Co recalls

Official ID Z-2988-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICA recall — Africando Foods LLC

Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list

Company / brand: Africando Foods recalls

Official ID H-1381-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT (Item 136990 recall — Horizon Organic Dairy, LLC

Product has the potential to be spoiled.

Company / brand: Horizon Organic Dairy recalls

Official ID H-1333-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Mehadrin Chocolate Leben recall — UPSTATE NIAGARA COOPERATIVE

Product may have been improperly pasteurized.

Company / brand: UPSTATE NIAGARA COOPERATIVE recalls

Official ID H-1332-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

Jalapeno Ranch recall — Jaime's Foods ATX, LLC

Undeclared Egg Allergen

Company / brand: Jaime's Foods ATX recalls

Official ID H-1301-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Byron White FORMULAS A-FNG Herbal Supplement 1 recall — Byron White Formulas, Inc.

Label does not declare walnuts in English

Company / brand: Byron White Formulas recalls

Official ID H-1278-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Byron White FORMULAS A-P Herbal Supplement 1 recall — Byron White Formulas, Inc.

Label does not declare walnuts in English

Company / brand: Byron White Formulas recalls

Official ID H-1277-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Byron White FORMULAS A-L Complex Herbal Supplement 1 recall — Byron White Formulas, Inc.

Label does not declare walnuts in English

Company / brand: Byron White Formulas recalls

Official ID H-1276-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with cocon recall — Lidl US TRADING

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coco…

Company / brand: Lidl US TRADING recalls

Official ID H-1275-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling recall — Lidl US TRADING

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coco…

Company / brand: Lidl US TRADING recalls

Official ID H-1274-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

bettergoods brand Pistachio Nut Butter recall — Botticelli Foods, LLC

Product may be contaminated with Salmonella.

Company / brand: Botticelli Foods recalls

Official ID H-1273-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Marketside Tomato Bisque Soup Kit recall — CUISINE, KETTLE

Product had a presumptive positive test result for Listeria monocytogenes

Company / brand: CUISINE recalls

Official ID H-1271-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bars Strawberry recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1269-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bars Black Cherry recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1268-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bars Tangerine recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1267-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bars Grape recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1266-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bar Watermelon recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1265-2026 · Official record ↗

FDA Class II · Food · September 2, 2026

Outshine Fruit Bars Strawberry recall — Dreyer's Grand Ice Cream Inc.

Foreign object: products may contain glass pieces

Company / brand: Dreyer's Grand Ice Cream recalls

Official ID H-1264-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

Addall XR Shot 1 single bottle recall — ZMB Enterprises

The product contains 1,4-DMAA, Phenylethylamine and Phenibut.

Company / brand: ZMB Enterprises recalls

Official ID H-1263-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB recall — Sirna and Sons Produce, Inc

Potential Salmonella Javiana contamination

Company / brand: Sirna and Sons Produce recalls

Official ID H-1262-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT recall — KHONG GUAN (HQ)

Undeclared peanuts.

Company / brand: KHONG GUAN (HQ) recalls

Official ID H-1260-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

Glutinous Rice Balls with Black Sesame Filling NET WT recall — KHONG GUAN (HQ)

Undeclared peanuts.

Company / brand: KHONG GUAN (HQ) recalls

Official ID H-1259-2026 · Official record ↗

FDA Class I · Food · September 2, 2026

Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base recall — H & U Inc. dba Sun Noodle

Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared …

Company / brand: H & U dba Sun Noodle recalls

Official ID H-1258-2026 · Official record ↗

FDA Class I · Drug · September 2, 2026

Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INC

Presence of Particulate matter.

Company / brand: B BRAUN MEDICAL recalls

Official ID D-0832-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Ramipril Capsules USP recall — Hikma Pharmaceuticals USA INC.

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Company / brand: Hikma Pharmaceuticals USA recalls

Official ID D-0831-2026 · Official record ↗

FDA Class I · Drug · September 2, 2026

Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLC

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Company / brand: Fresenius Kabi USA recalls

Official ID D-0827-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Paxil CR recall — Apotex Corp.

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Company / brand: Apotex recalls

Official ID D-0804-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Acthar Gel (repository corticotropin injection) recall — Mallinckrodt Hospital Products Inc.

Presence of particulate matter: glass and stopper piece

Company / brand: Mallinckrodt Hospital Products recalls

Official ID D-0803-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Zicam recall — Church & Dwight Co., Inc.

CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Company / brand: Church & Dwight Co recalls

Official ID D-0790-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Clobetasol Propionate Cream USP recall — Lupin Pharmaceuticals Inc.

Failed content uniformity specifications.

Company / brand: Lupin Pharmaceuticals recalls

Official ID D-0789-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0786-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0785-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0784-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0783-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0782-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0781-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0780-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0779-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0778-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0777-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0776-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Official ID D-0775-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

American Contract Systems medical procedure kits and trays labeled as recall — American Contract Systems Inc

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: American Contract Systems recalls

Official ID Z-2990-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

American Contract Systems medical procedure kits and trays labeled as recall — American Contract Systems Inc

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…

Company / brand: American Contract Systems recalls

Official ID Z-2989-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Brand Name recall — restor3d Inc.

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Company / brand: restor3d recalls

Official ID Z-2987-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers recall — ConvaTec, Inc

Urostomy Pouches may leak from cap during use.

Company / brand: ConvaTec recalls

Official ID Z-2986-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Fort Defiance Industries (FDI) recall — Fort Defiance Industries, LLC

The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable f…

Company / brand: Fort Defiance Industries recalls

Official ID Z-2983-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

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

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or u…

Company / brand: Medtronic MiniMed recalls

Official ID Z-2982-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

MiniMed 670G Insulin Pump recall — Medtronic MiniMed, Inc.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or u…

Company / brand: Medtronic MiniMed recalls

Official ID Z-2981-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

MiniMed 640G Insulin Pump recall — Medtronic MiniMed, Inc.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or u…

Company / brand: Medtronic MiniMed recalls

Official ID Z-2980-2026 · Official record ↗

FDA Class I · Medical device · August 26, 2026

BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall — BMC Medical Co., Ltd.

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Company / brand: BMC Medical Co recalls

Official ID Z-2979-2026 · Official record ↗

FDA Class I · Medical device · August 26, 2026

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall — Boston Scientific Corporation

Potential for arterial sheath tip separation or partial tip separation during use.

Company / brand: Boston Scientific recalls

Official ID Z-2978-2026 · Official record ↗

FDA Class I · Medical device · August 26, 2026

Boston Scientific ENROUTE Transcarotid Neuroprotection System recall — Boston Scientific Corporation

Potential for arterial sheath tip separation or partial tip separation during use.

Company / brand: Boston Scientific recalls

Official ID Z-2977-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Beckman Coulter recall — Siemens Healthcare Diagnostics, Inc.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o…

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-2976-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Syva EMIT 2000 Quinidine Assay REF recall — Siemens Healthcare Diagnostics, Inc.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o…

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-2975-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of …

Company / brand: Beckman Coulter recalls

Official ID Z-2974-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of …

Company / brand: Beckman Coulter recalls

Official ID Z-2973-2026 · Official record ↗

FDA Class III · Medical device · August 26, 2026

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall — Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Company / brand: Paragon 28 recalls

Official ID Z-2972-2026 · Official record ↗

FDA Class III · Medical device · August 26, 2026

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall — Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Company / brand: Paragon 28 recalls

Official ID Z-2971-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Blanketrol III recall — Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

Company / brand: Gentherm Medical recalls

Official ID Z-2970-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Innercool Coolblue Console recall — Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

Company / brand: Gentherm Medical recalls

Official ID Z-2969-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Blanketrol II Model 222S recall — Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

Company / brand: Gentherm Medical recalls

Official ID Z-2968-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Paragonix Technologies Inc recall — Paragonix Technologies Inc.

Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Company / brand: Paragonix Technologies recalls

Official ID Z-2967-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall — Siemens Healthcare Diagnostics Products Ltd.

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Company / brand: Siemens Healthcare Diagnostics Products recalls

Official ID Z-2966-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall — Siemens Healthcare Diagnostics Products Ltd.

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Company / brand: Siemens Healthcare Diagnostics Products recalls

Official ID Z-2965-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Halyard LAVH PACK recall — AVID Medical, Inc.

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Company / brand: AVID Medical recalls

Official ID Z-2964-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

GETINGE Y SENSOR Module recall — Maquet Critical Care AB

The module did not undergo electrical safety tests and functional tests during production.

Company / brand: Maquet Critical Care AB recalls

Official ID Z-2963-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Suture Cinch Long 1pk recall — Boston Scientific Corporation

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Company / brand: Boston Scientific recalls

Official ID Z-2962-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

OverStitch Suture Cinch recall — Boston Scientific Corporation

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Company / brand: Boston Scientific recalls

Official ID Z-2961-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

TD Navio Maxi Speech Generating Device Model/Catalog Number recall — Tobii Dynavox Llc

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. …

Company / brand: Tobii Dynavox recalls

Official ID Z-2960-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

TD Navio Midi Speech Generating Device Model/Catalog Number recall — Tobii Dynavox Llc

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. …

Company / brand: Tobii Dynavox recalls

Official ID Z-2959-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Arrow-LOK Implant recall — Arrowhead DE LLC

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Company / brand: Arrowhead DE recalls

Official ID Z-2958-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Brand Name recall — Kico Knee Innovation Company

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Company / brand: Kico Knee Innovation Company recalls

Official ID Z-2957-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Cardiac Workstation 7000 recall — Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

Company / brand: Philips North America recalls

Official ID Z-2956-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Cardiac Workstation 5000 recall — Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

Company / brand: Philips North America recalls

Official ID Z-2955-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Dentsply Sirona Capsule Mixer Model No recall — SDI Limited

Potential for electrical discharge from unit when unplugged.

Company / brand: SDI recalls

Official ID Z-2954-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

One-Piece Guedel Airway recall — Intersurgical Inc

Devices could potentially be occluded or partially occluded.

Company / brand: Intersurgical recalls

Official ID Z-2953-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

One-Piece Guedel Airway recall — Intersurgical Inc

Devices could potentially be occluded or partially occluded.

Company / brand: Intersurgical recalls

Official ID Z-2952-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Hamilton Microlab STAR Liquid Handler recall — Foundation Medicine, Inc.

Software issue that can cause an increase in spontaneous software closures.

Company / brand: Foundation Medicine recalls

Official ID Z-2951-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

EndoFLIP System that includes recall — Covidien, LLC

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

Company / brand: Covidien recalls

Official ID Z-2950-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Ami HTX recall — Spectral Instruments Inc

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Company / brand: Spectral Instruments recalls

Official ID Z-2940-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Lago X recall — Spectral Instruments Inc

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Company / brand: Spectral Instruments recalls

Official ID Z-2939-2026 · Official record ↗

FDA Class I · Medical device · August 26, 2026

BD Needle Kit for Powered Driver 15mm x 15Ga recall — Bard Access Systems, Inc.

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may exp…

Company / brand: Bard Access Systems recalls

Official ID Z-2872-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Get Fresh Produce Jalapeno Peppers recall — GET FRESH PRODUCE

Potential Salmonella contamination

Company / brand: GET FRESH PRODUCE recalls

Official ID H-1257-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Dairyland Produce recall — Dairyland Produce, LLC

Jalapenos may be contaminated with Salmonella.

Company / brand: Dairyland Produce recalls

Official ID H-1256-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Mango Pineapple Salsa sold as a condiment in Caribbean Mango Pineapple Turkey recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1255-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Salsa recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1254-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Trio Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1253-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Spicy Guacamole Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1252-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Roasted Corn Guacamole Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1251-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Pomegranate Guacamole Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1250-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Medium Pico de Gallo Guacamole Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1249-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Spicy Guacamole Dip No Tomatoes recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1248-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Mild Guacamole Dip No Tomatoes recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1247-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Whole Foods Mild Guacamole Dip recall — WFM Purchasing, LP

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Company / brand: WFM Purchasing recalls

Official ID H-1246-2026 · Official record ↗

FDA Class II · Food · August 26, 2026

Gifford's HomeMaine ice cream brand POWER PLAY FUDGE recall — Gifford's Dairy, Inc.

Potential foreign object contamination: rubber pieces

Company / brand: Gifford's Dairy recalls

Official ID H-1245-2026 · Official record ↗

FDA Class II · Food · August 26, 2026

Product is Potato Sourdough Bread and sold under three following names recall — Grand Central Bakery - Oregon Inc. dba Grand Central Bakery, Inc.

Foreign object: May contain metal pieces

Company / brand: Grand Central Bakery - Oregon dba Grand Central Bakery recalls

Official ID H-1244-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1 recall — Lidl US TRADING

Salmonella. The firm received a positive test result of Salmonella in the product.

Company / brand: Lidl US TRADING recalls

Official ID H-1243-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Jalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging recall — Coast Citrus Distributors

Potential Salmonella Javiana contamination

Company / brand: Coast Citrus Distributors recalls

Official ID H-1242-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Organic Whole Mixed Berries recall — Publix Super Markets, Inc.

Due to potential E. coli O145:H28 contamination

Company / brand: Publix Super Markets recalls

Official ID H-1241-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Organic Whole Mixed Berries recall — Publix Super Markets, Inc.

Due to potential E. coli O145:H28 contamination

Company / brand: Publix Super Markets recalls

Official ID H-1240-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Organic Whole Blueberries recall — Publix Super Markets, Inc.

Due to potential E. coli O145:H28 contamination

Company / brand: Publix Super Markets recalls

Official ID H-1239-2026 · Official record ↗

FDA Class I · Food · August 26, 2026

Organic Whole Blueberries recall — Publix Super Markets, Inc.

Due to potential E. coli O145:H28 contamination

Company / brand: Publix Super Markets recalls

Official ID H-1238-2026 · Official record ↗

FDA Class III · Food · August 26, 2026

Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3 recall — Prospector Popcorn, LLC

Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).

Company / brand: Prospector Popcorn recalls

Official ID H-1235-2026 · Official record ↗

FDA Class III · Food · August 26, 2026

Prospector Popcorn Fudge Brownie Gourmet Popcorn 1 recall — Prospector Popcorn, LLC

Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).

Company / brand: Prospector Popcorn recalls

Official ID H-1234-2026 · Official record ↗

FDA Class III · Food · August 26, 2026

Prospector Popcorn Maple Walnut Ice Cream Gourmet Popcorn 3 recall — Prospector Popcorn, LLC

Inaccurately declared nutrients including Potassium (overstated), Calcium (overstated), and Iron (understated).

Company / brand: Prospector Popcorn recalls

Official ID H-1233-2026 · Official record ↗

FDA Class II · Food · August 26, 2026

Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1 recall — Prospector Popcorn, LLC

Inaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated).

Company / brand: Prospector Popcorn recalls

Official ID H-1232-2026 · Official record ↗

FDA Class II · Food · August 26, 2026

Protein Cereal Cocoa Crunch recall — Nutrient Foods, LLC

Soy not declared in the contains statement.

Company / brand: Nutrient Foods recalls

Official ID H-1231-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

niCARdipine Hydrochloride Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0802-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Tralement (trace elements injection 4* recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0801-2026 · Official record ↗

FDA Class I · Drug · August 26, 2026

Papaverine HCl Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0800-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Multrys (Trace Elements Injection 4 recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0799-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Selenious Acid Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0798-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

ACETYLCYSTEINE SOLUTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0797-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

ACETYLCYSTEINE SOLUTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0796-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Atropine Sulfate injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0795-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

AMINAOCAPROIC ACID INJECTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0794-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Cyanocobalamin injection USP recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0793-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Cyanocobalamin injection USP recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0792-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Nitroglycerin injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Official ID D-0791-2026 · Official record ↗

FDA Class I · Drug · August 26, 2026

Morphine Sulfate Injection recall — Fresenius Kabi USA, LLC

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Company / brand: Fresenius Kabi USA recalls

Official ID D-0788-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Acamprosate Calcium recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

Company / brand: Mylan Pharmaceuticals recalls

Official ID D-0774-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Carbamazepine Tablets recall — Golden State Medical Supply Inc.

CGMP deviations: tablets with black specks.

Company / brand: Golden State Medical Supply recalls

Official ID D-0771-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Carbamazepine Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Official ID D-0770-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Libtayo (cemiplimab-rwlc) Injection recall — Regeneron Pharmaceuticals Inc

Lack of Assurance of Sterility

Company / brand: Regeneron Pharmaceuticals recalls

Official ID D-0767-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

PEMRYDI RTU(pemetrexed injection) recall — Shilpa Medicare Limited

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Company / brand: Shilpa Medicare recalls

Official ID D-0765-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

PEMRYDI RTU (pemetrexed injection) recall — Shilpa Medicare Limited

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Company / brand: Shilpa Medicare recalls

Official ID D-0764-2026 · Official record ↗

FDA Class II · Food · August 19, 2026

Lyle Style Mild Bloody Mary Mix recall — Lyle Style

Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.

Company / brand: Lyle Style recalls

Official ID EVT-99517-9nos1e · Official record ↗

FDA Not Yet Classified · Drug · August 19, 2026

Cefazolin in Dextrose recall — Baxter Healthcare Corporation

Presence of Particulate Matter

Company / brand: Baxter Healthcare recalls

Official ID EVT-99463-1krekt6 · Official record ↗

FDA Not Yet Classified · Food · August 19, 2026

MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID EVT-99453-wgl5uq · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2949-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2948-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2947-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2946-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2945-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2944-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2943-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Company / brand: Cardinal Health 200 recalls

Official ID Z-2942-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code recall — BD SWITZERLAND SARL

Products may not have received adequate sterilization processing.

Company / brand: BD SWITZERLAND SARL recalls

Official ID Z-2941-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall — Erbe USA Inc

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the r…

Company / brand: Erbe USA recalls

Official ID Z-2938-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

ProNephro AKI (NGAL) Reagent Kit (100 tests) recall — Bioporto Diagnostics A/S

The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring o…

Company / brand: Bioporto Diagnostics A/S recalls

Official ID Z-2937-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

BIOFIRE Respiratory Panel 2 recall — BioFire Diagnostics, LLC

Due to increase in false negative results

Company / brand: BioFire Diagnostics recalls

Official ID Z-2936-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Straumann Bone Level Tapered (BLT) Implant recall — Straumann USA LLC

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest…

Company / brand: Straumann USA recalls

Official ID Z-2935-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Endo-Model recall — Waldemar Link GmbH & Co. KG (Mfg Site)

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified s…

Company / brand: Waldemar Link & Co. KG (Mfg Site) recalls

Official ID Z-2934-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

OBP Medical recall — OBP Medical Corporation

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the hea…

Company / brand: OBP Medical recalls

Official ID Z-2933-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Philips Azurion recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Official ID Z-2932-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Philips Azurion Rystem recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropria…

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Official ID Z-2931-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

GLIDESHEATH SLENDER A-KIT 6F 10CM recall — Terumo Medical Corporation

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Company / brand: Terumo Medical recalls

Official ID Z-2930-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

GM Helix Implant recall — Straumann USA LLC

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i…

Company / brand: Straumann USA recalls

Official ID Z-2929-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Allura Xper FD recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Firmware issue potentially leading to loss of geometry movements.

Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls

Official ID Z-2928-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall — Remel Europe Ltd.

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Company / brand: Remel Europe recalls

Official ID Z-2927-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…

Company / brand: Medline Industries recalls

Official ID Z-2926-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…

Company / brand: Medline Industries recalls

Official ID Z-2925-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…

Company / brand: Medline Industries recalls

Official ID Z-2924-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…

Company / brand: Medline Industries recalls

Official ID Z-2923-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall — Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…

Company / brand: Covidien recalls

Official ID Z-2922-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall — Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…

Company / brand: Covidien recalls

Official ID Z-2921-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU recall — Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…

Company / brand: Covidien recalls

Official ID Z-2920-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P recall — Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…

Company / brand: Covidien recalls

Official ID Z-2919-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall — Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…

Company / brand: Covidien recalls

Official ID Z-2918-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF recall — Galt Medical Corporation

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Company / brand: Galt Medical recalls

Official ID Z-2917-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

Brand Name recall — Spacelabs Healthcare, Inc.

Due to off-the-shelf display port component that has audio/video failures

Company / brand: Spacelabs Healthcare recalls

Official ID Z-2916-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Company / brand: W L Gore & Associates recalls

Official ID Z-2915-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Company / brand: W L Gore & Associates recalls

Official ID Z-2914-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

navify Digital Pathology (on-prem) v2 recall — Ventana Medical Systems, Inc.

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Company / brand: Ventana Medical Systems recalls

Official ID Z-2913-2026 · Official record ↗

FDA Class II · Medical device · August 19, 2026

BOBBY Balloon Guide Catheter REF recall — MICROVENTION INC.

Due to an increase rate of balloon pinhole defects.

Company / brand: MICROVENTION recalls

Official ID Z-2912-2026 · Official record ↗

FDA Class I · Medical device · August 19, 2026

Brand Name recall — Spectra Medical Devices, Llc

Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganism…

Company / brand: Spectra Medical Devices recalls

Official ID Z-2873-2026 · Official record ↗

FDA Class I · Medical device · August 19, 2026

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recall — Baxter Healthcare Corporation

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

Company / brand: Baxter Healthcare recalls

Official ID Z-2766-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Cibus Fresh recall — Piazza Produce (dba CIBUS Fresh)

Possible Cyclospora Contamination

Company / brand: Piazza Produce (dba CIBUS Fresh) recalls

Official ID H-1300-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

TAYLOR FARMS BLEND LETT/ROM BLEND WITH BAG 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1299-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1298-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Cross Valley Farms BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1297-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

TAYLOR FARMS LETTUCE SALAD W/BAG 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1296-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1295-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

PEAK LETTUCE SALAD W/BAG 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1294-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

MARKON LETTUCE SALAD MIX 4/5# MARKON LETTUCE SALAD WITH SEP BAG 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1293-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Cross Valley Farms LETTUCE SALAD MIX 4/5# Cross Valley Farms LETTUCE SALAD WITH SEP BAG 4/ recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1292-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# NATIONAL TAYLOR FARMS BLEND GARDEN SALAD MI recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1291-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

SYSCO BLEND LETT/ROM 50/50 NOCLR 4/5# SYSCO BLEND LETT/ROM 70/30 NOCOLR 4/5# SYSCO BLEND L recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1290-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

MARKON BLEND LETT/ROM 50/50 NOCLR 4/5# MARKON BLEND LETT/ROM 80/20 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1289-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Cross Valley Farms BLEND LETT/ROM 50/50 NOCLR 4/5# Cross Valley Farms BLEND LETT/ROM 80/20 recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1288-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

YUM LETTUCE SHREDDED 1/4" 6/5# Iceberg only products recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1287-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Jack in the Box 1/8" SHRED LETTUCE 4/5# Iceberg only products recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1286-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

TAYLOR FARMS LETTUCE CHOP 1X1" 4/4# TAYLOR FARMS LETTUCE CHOP 1X1" 8/2# TAYLOR FARMS LETTU recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1285-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

SYSCO LETTUCE CHOP 4/5# SYSCO LETTUCE SHRED 1/8" 4/5# Iceberg only products recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1284-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

SUBWAY SHRED LETTUCE 1/4" 4/5# Iceberg only products recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1283-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1282-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

MARKON LETTUCE CHOP 4/5# MARKON LETTUCE SHRED 1/4" 4/5# MARKON LETTUCE SHRED 1/8" 4/5# MAR recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1281-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

MARKETSIDE ICEBERG SALAD 10/24 oz recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1280-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Cross Valley Farms LETTUCE CHOP 4/5# Cross Valley Farms LETTUCE SHRED 1/4" 4/5# Cross Vall recall — Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Company / brand: Taylor Farms de Mexico S. de R.L. de C.V recalls

Official ID H-1279-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Aquafaba Powder recall — 529 COMMERCE, LLC

Undeclared Egg

Company / brand: 529 COMMERCE recalls

Official ID H-1270-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Grade A White In-shell Chicken eggs packaged in the following configurations recall — MIDWEST POULTRY SERVC C/O H & LELECTRIC

Possible Salmonella Enteritidis

Company / brand: MIDWEST POULTRY SERVC C/O H & LELECTRIC recalls

Official ID H-1230-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Grade A Brown In-shell Chicken eggs packaged in the following configurations recall — MIDWEST POULTRY SERVC C/O H & LELECTRIC

Possible Salmonella Enteritidis

Company / brand: MIDWEST POULTRY SERVC C/O H & LELECTRIC recalls

Official ID H-1229-2026 · Official record ↗

FDA Class I · Food · August 19, 2026

Dark Chocolate Coconut Almond Bites recall — Bazzini LLC

Undeclared peanuts

Company / brand: Bazzini recalls

Official ID H-1228-2026 · Official record ↗

FDA Class III · Food · August 19, 2026

Honeyville YELLOW COLOR 1 GALLON NFI recall — FlavorsandColor.Com

Undeclared Red #40.

Company / brand: FlavorsandColor.Com recalls

Official ID H-1225-2026 · Official record ↗

FDA Class II · Food · August 19, 2026

Vodka Tomato Sauce recall — SHEANDRO LLC

Label declares cream and cheese, but Milk is not declared

Company / brand: SHEANDRO recalls

Official ID H-1224-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Cefazolin in Dextrose recall — Baxter Healthcare Corporation

Presence of Particulate Matter

Company / brand: Baxter Healthcare recalls

Official ID D-0787-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Optiray Imaging Bulk Package-350 recall — Liebel-Flarsheim Company LLC

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Company / brand: Liebel-Flarsheim Company recalls

Official ID D-0773-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Glutathione (MDV) recall — Victory Medical Center Pharmacy

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Company / brand: Victory Medical Center Pharmacy recalls

Official ID D-0772-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Kian Pee Wan Capsules recall — Buy-Herbal

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Company / brand: Buy-Herbal recalls

Official ID D-0769-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall — Heritage Pharmaceuticals Inc

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Company / brand: Heritage Pharmaceuticals recalls

Official ID D-0768-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

CLEAR EYES Maximum Itchy Eye Relief recall — Prestige Brands Holdings

Lack of assurance of sterility. The recall is due to potential contamination

Company / brand: Prestige Brands Holdings recalls

Official ID D-0766-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SILDENAFIL CITRATE USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Official ID D-0763-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

TADALAFIL USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Official ID D-0762-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

TADALAFIL USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Official ID D-0761-2026 · Official record ↗

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