FDA recalls

2,784 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing 1–300, newest first.

FDA Not Yet Classified · Food · October 14, 2026

SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT recall — Sierra Nevada Cheese Company, Inc

Potential contamination due to E. coli O26:H11.

Company / brand: Sierra Nevada Cheese Company recalls

Official ID EVT-99986-1nddy38 · Official record ↗

FDA Not Yet Classified · Drug · October 14, 2026

Tri-Immune Boost (Glutathione recall — Centric Compounding LLC

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

Company / brand: Centric Compounding recalls

Official ID EVT-99860-15i85aw · Official record ↗

FDA Class II · Medical device · October 14, 2026

Intellijoint Navigation System recall — Intellijoint Surgical, Inc.

A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an…

Company / brand: Intellijoint Surgical recalls

Official ID Z-0119-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HexaVue Focus Integration System recall — Steris Corporation

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a docum…

Company / brand: Steris recalls

Official ID Z-0118-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

TufTex¿ Over-the-Wire Embolectomy Catheter recall — LeMaitre Vascular, Inc.

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Company / brand: LeMaitre Vascular recalls

Official ID Z-0117-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

T1 Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0116-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

cPM Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0115-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Passport Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0114-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneView Series recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0113-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Panorama and Telemetry Monitoring System recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0112-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneVision Series Telemetry Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0111-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

BeneVision N1 and N-Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0110-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

ePM Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Official ID Z-0109-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Alphenix INFX-8000C/B5 recall — Canon Medical System, USA, INC.

Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio…

Company / brand: Canon Medical System recalls

Official ID Z-0108-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

SEDIPLAST recall — POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be fo…

Company / brand: POLYMEDCO recalls

Official ID Z-0107-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ABD HYSTERECTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0106-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

GYN LAPAROSCOPY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0105-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

MAJOR PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0104-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

UROLOGY MAJOR recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0103-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HEART PREP TRAY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0102-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DAVINCI LAP/GYN recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0101-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

PLASTICS TRAY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0100-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

LAPAROSCOPIC PROSTATECTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0099-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ROBOTIC PROSTATECTOMY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0098-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

PACK OPEN HEART CFH recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0097-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

CRANIOTOMY PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0096-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ENDOVASCULAR PACK recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0095-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

ADULT HEART TRAY SHANDS JACKS recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0094-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

GYN LAPAROSCOPY/LAPAROTOMY recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0093-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DAVINCI TRUCUSTOM BUNDLE recall — AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Company / brand: AVID Medical recalls

Official ID Z-0092-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Onkos Surgical Inc recall — Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Company / brand: Onkos Surgical recalls

Official ID Z-0091-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Onkos Surgical Inc recall — Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Company / brand: Onkos Surgical recalls

Official ID Z-0090-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Product Name recall — Nihon Kohden America LLC

Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds…

Company / brand: Nihon Kohden America recalls

Official ID Z-0089-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Brand Name recall — Medtronic MiniMed, Inc.

Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in o…

Company / brand: Medtronic MiniMed recalls

Official ID Z-0088-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Rollator recall — Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…

Company / brand: Medline Industries recalls

Official ID Z-0087-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Rollator recall — Medline Industries, LP

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…

Company / brand: Medline Industries recalls

Official ID Z-0086-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

BARD EP XT DECAPOLAR STEERABLE recall — Stryker Sustainability Solutions

Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization,…

Company / brand: Stryker Sustainability Solutions recalls

Official ID Z-0085-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DxC 500 AU Clinical Chemistry Analyzers recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us…

Company / brand: Beckman Coulter recalls

Official ID Z-0084-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DxC 500i Clinical Analyzer Modules recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use …

Company / brand: Beckman Coulter recalls

Official ID Z-0083-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Sperm Ab ELISA recall — DRG International, Inc.

Potential for false negative patient results.

Company / brand: DRG International recalls

Official ID Z-0082-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Battle Bandage recall — Safeguard US Operating LLC

Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s…

Company / brand: Safeguard US Operating recalls

Official ID Z-0081-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Glypto Device recall — Limitless Cryo Spa LLC

Lack of 510(k) clearance.

Company / brand: Limitless Cryo Spa recalls

Official ID Z-0080-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Presource Packs containing Medtronic Microstream Components recall — Cardinal Health 200, LLC

Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the pati…

Company / brand: Cardinal Health 200 recalls

Official ID Z-0079-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Spectral CT and Spectral CT 7500 RT recall — PHILIPS MEDICAL SYSTEMS

Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

Company / brand: PHILIPS MEDICAL SYSTEMS recalls

Official ID Z-0078-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

HALYARD Laparoscopy Comprehensive Pack II REF recall — GRI Medical & Electronic Technology Co., Ltd.

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Company / brand: GRI Medical & Electronic Technology Co recalls

Official ID Z-0077-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

Brand Name recall — QUANTUM OPS Inc

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Company / brand: QUANTUM OPS recalls

Official ID Z-0076-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological Steam Test Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0075-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological Steam Test Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0074-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0073-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0072-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0071-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall — Steris Corporation

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…

Company / brand: Steris recalls

Official ID Z-0070-2027 · Official record ↗

FDA Class III · Medical device · October 14, 2026

Generic Name recall — Medical Action Industries, Inc. 306

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Company / brand: Medical Action Industries recalls

Official ID Z-0069-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Croissant recall — J K Patisserie & Bakery LLC

Egg was not declared in the Contains statement.

Company / brand: J K Patisserie & Bakery recalls

Official ID H-0027-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Chocolate Chip Cookies packaged in a cardboard box recall — J K Patisserie & Bakery LLC

Soy was not declared in the Contains statement.

Company / brand: J K Patisserie & Bakery recalls

Official ID H-0026-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Lemon Blueberry Loaf packaged in a cardboard box recall — J K Patisserie & Bakery LLC

Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement.

Company / brand: J K Patisserie & Bakery recalls

Official ID H-0025-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Saint Francis Apizza Frozen Supreme Pizza recall — Saint Francis Apizza LLC

Undeclared soy allergen: soybean oil and soy lecithin

Company / brand: Saint Francis Apizza recalls

Official ID H-0024-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Saint Francis Apizza Frozen Mushroom & Onion Pizza recall — Saint Francis Apizza LLC

Undeclared soy allergen: soybean oil and soy lecithin

Company / brand: Saint Francis Apizza recalls

Official ID H-0023-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Saint Francis Apizza Frozen Cheese Pizza recall — Saint Francis Apizza LLC

Undeclared soy allergen: soybean oil and soy lecithin

Company / brand: Saint Francis Apizza recalls

Official ID H-0022-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Saint Francis Apizza Frozen Pepperoni Pizza recall — Saint Francis Apizza LLC

Undeclared soy allergen: soybean oil and soy lecithin

Company / brand: Saint Francis Apizza recalls

Official ID H-0021-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC recall — SWEET SENSI

Staphylococcus aureus detected in product.

Company / brand: SWEET SENSI recalls

Official ID H-0020-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

biQ-FEL recall — A&P CREATIONS

Product contains undeclared Sildenafil and Tadalafil.

Company / brand: A&P CREATIONS recalls

Official ID H-0017-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

X10 Natural Enhancement Supplement recall — A&P CREATIONS

Product contains undeclared Sildenafil and Tadalafil.

Company / brand: A&P CREATIONS recalls

Official ID H-0016-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

QUESO PALMITA recall — QUESO PALMITA GP LLC

Undeclared milk, cheese declared

Company / brand: QUESO PALMITA GP recalls

Official ID H-0015-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black letteri recall — GIAS FOOD INC.

Contamination with Listeria monocytogenes

Company / brand: GIAS FOOD recalls

Official ID H-0014-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

Berlin Seeds Alfalfa Sprouting Seeds recall — Berlin Seeds

Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination.

Company / brand: Berlin Seeds recalls

Official ID H-0013-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Cranberry Chicken Salad Wedge 4 recall — FRESHPOINT CENTRAL FLORIDA, INC.

The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contain…

Company / brand: FRESHPOINT CENTRAL FLORIDA recalls

Official ID H-0012-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

Donutful Chocolate Dipped Vanilla Cake Donuts - 7 recall — The Better Bakehouse Snack Company

Undeclared Milk.

Company / brand: The Better Bakehouse Snack Company recalls

Official ID H-0011-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

28 oz recall — Pepsico Inc

Undeclared Yellow No. 6 and/or Yellow No. 5

Company / brand: Pepsico recalls

Official ID H-0009-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container with clear recall — WinCo Foods LLC

Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue.

Company / brand: WinCo Foods recalls

Official ID H-0008-2027 · Official record ↗

FDA Class II · Food · October 14, 2026

Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G recall — G L Mezzetta Inc

Potential contamination with foreign objects: mice.

Company / brand: G L Mezzetta recalls

Official ID H-0007-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

LEASA Alfalfa Sprouts recall — LEASA Industries Co., Inc.

Seeds may have been contaminated with E.coli

Company / brand: LEASA Industries Co recalls

Official ID H-0003-2027 · Official record ↗

FDA Class I · Food · October 14, 2026

LEASA Living Alfalfa Sprouts recall — LEASA Industries Co., Inc.

Seeds may have been contaminated with E. coli

Company / brand: LEASA Industries Co recalls

Official ID H-0002-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Apothecary NAD+ Injection 200 mg/mL recall — Apothecary Pharma LLC

Lack of Assurance of Sterility

Company / brand: Apothecary Pharma recalls

Official ID D-0037-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tirzepatide Injection recall — Apothecary Pharma LLC

Lack of Assurance of Sterility

Company / brand: Apothecary Pharma recalls

Official ID D-0036-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream UPS recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Official ID D-0035-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream USP recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Official ID D-0034-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream USP recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Official ID D-0033-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0032-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0031-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0030-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0029-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0028-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0027-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0026-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0025-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0024-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0023-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0022-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0021-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SERMORELIN ACETATE 1 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0020-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0019-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE 3 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0018-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE 26 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Official ID D-0017-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

IMAAVY (nipocalimab-aahu) Injection recall — J&J INNOVATIVE MEDICINE

Presence of particulate matter.

Company / brand: J&J INNOVATIVE MEDICINE recalls

Official ID D-0016-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Fosfomycin Tromethamine Granules for Oral Solution recall — Cipla USA, Inc.

Failed Impurities/Degradation Specifications

Company / brand: Cipla USA recalls

Official ID D-0014-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Lidocaine Ointment USP recall — Preferred Pharmaceuticals, Inc.

Failed Content Uniformity Specifications

Company / brand: Preferred Pharmaceuticals recalls

Official ID D-0013-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Biospectra Tris/Tromethamine recall — BioSpectra, Inc.

Failed stability specifications

Company / brand: BioSpectra recalls

Official ID D-0012-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0009-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Eye Drops Redness Relief (Glycerin 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0008-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Eye Drops recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0007-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Lubricant Dry Eye Relief Eye Drops recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0006-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Eye Drops MAXIMUM recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0005-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile EYE DROPS Advanced Relief recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0004-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile EYE DROPS AC (tetrahydrozoline HCl 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0003-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Official ID D-0002-2027 · Official record ↗

FDA Not Yet Classified · Drug · October 7, 2026

amazon recall — Aurobindo Pharma USA Inc

Discoloration: consumer complaints received for discolored tablets

Company / brand: Aurobindo Pharma USA recalls

Official ID EVT-99934-1f1l4x9 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Atellica CH Revised C-Reactive Protein (RCRP) recall — Siemens Healthcare Diagnostics, Inc.

The potential for falsely elevated results.

Company / brand: Siemens Healthcare Diagnostics recalls

Official ID Z-3335-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

CHARLOTTE CLAW Screw recall — Wright Medical Technology, Inc.

Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve…

Company / brand: Wright Medical Technology recalls

Official ID Z-3334-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

HOPKINS Telescope 30¿ recall — Karl Storz Endoscopy

Due to incorrect inside packaging label for eyepiece.

Company / brand: Karl Storz Endoscopy recalls

Official ID Z-3333-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 RE recall — Beckman Coulter Mishima K.K.

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the …

Company / brand: Beckman Coulter Mishima K.K recalls

Official ID Z-3332-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Penumbra Inc.

Due to manufacturing issues reperfusion catheters may fracture.

Company / brand: Penumbra recalls

Official ID Z-3331-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Tandem Diabetes Care, Inc.

A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle …

Company / brand: Tandem Diabetes Care recalls

Official ID Z-3330-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall — Olympus Corporation of the Americas

While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.

Company / brand: Olympus of the Americas recalls

Official ID Z-3329-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — SPECTRUM MEDICAL SRL

Due to blood-to-glycol leak in the heat exchanger.

Company / brand: SPECTRUM MEDICAL SRL recalls

Official ID Z-3328-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — SPECTRUM MEDICAL SRL

Due to blood-to-glycol leak in the heat exchanger.

Company / brand: SPECTRUM MEDICAL SRL recalls

Official ID Z-3327-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code recall — Micro Therapeutics, Inc.

Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

Company / brand: Micro Therapeutics recalls

Official ID Z-3326-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3325-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Travel Air recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3324-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Impulsator recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3323-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3322-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3321-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

In-Line Valve recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3320-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Intrapulmonary Percussive Ventilation recall — Percussionaire Corporation

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…

Company / brand: Percussionaire recalls

Official ID Z-3319-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Evolution upgrade 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3318-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3317-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade dStream recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3316-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3315-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to dStream for 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3314-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3313-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 5300 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3312-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Elition S and Ingenia Elition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3311-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Ambition S and Ingenia Ambition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3310-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 3 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3309-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3308-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Blue Seal SE and Blue Seal XE recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Company / brand: Philips North America recalls

Official ID Z-3307-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

NOxBOXi Nitric Oxide Delivery System recall — NOXBOX LTD

Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Company / brand: NOXBOX recalls

Official ID Z-3306-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall — Merit Medical Systems, Inc.

Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, whi…

Company / brand: Merit Medical Systems recalls

Official ID Z-3305-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS MV pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-3304-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS MV+G pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-3303-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS R+G pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-3302-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

PALACOS R pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Official ID Z-3301-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Lateral Telescope 70 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Company / brand: Olympus of the Americas recalls

Official ID Z-3300-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Company / brand: Olympus of the Americas recalls

Official ID Z-3299-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Official ID Z-3298-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Official ID Z-3297-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Official ID Z-3296-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall — Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl…

Company / brand: Cardinal Health 200 recalls

Official ID Z-3295-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Official ID Z-3294-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Official ID Z-3293-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall — American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U…

Company / brand: American Contract Systems recalls

Official ID Z-3292-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Official ID Z-3291-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Official ID Z-3290-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — American Nitrile Operations Llc

Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading…

Company / brand: American Nitrile Operations recalls

Official ID Z-3289-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3288-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3287-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3286-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3285-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3284-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Positron Emission Tomography and Computed Tomography System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3283-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3282-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3281-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3280-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3279-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3278-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single …

Company / brand: Shanghai United Imaging Healthcare Co recalls

Official ID Z-3277-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Philips IntraSight Plus REF recall — Volcano Corp

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Company / brand: Volcano recalls

Official ID Z-3276-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number recall — Bard Peripheral Vascular Inc

Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E0…

Company / brand: Bard Peripheral Vascular recalls

Official ID Z-3275-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Urine hCG recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Official ID Z-3274-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Urine hCG Strip recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Official ID Z-3273-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Fisher Scientific Sure-Vue Serum/Urine hCG recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Official ID Z-3272-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

McKesson CONSULT hCG Urine Cassette recall — Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Company / brand: Alere San Diego recalls

Official ID Z-3271-2026 · Official record ↗

FDA Class III · Medical device · October 7, 2026

HeartSine samaritan PAD (Public Access Defibrillator) recall — HeartSine Technologies Ltd

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Company / brand: HeartSine Technologies recalls

Official ID Z-3270-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

VentStar Resus Neo recall — Draeger, Inc.

Potential cracks in the hose, which could lead to leakage or the hose falling off.

Company / brand: Draeger recalls

Official ID Z-3252-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LP

Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…

Company / brand: Medline Industries recalls

Official ID Z-3228-2026 · Official record ↗

FDA Class I · Medical device · October 7, 2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LP

Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…

Company / brand: Medline Industries recalls

Official ID Z-3227-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Philips Medical Systems Technologies Ltd recall — Philips North America Llc

The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t…

Company / brand: Philips North America recalls

Official ID Z-3155-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

NovaSeq 6000Dx including DRAGEN Server recall — Illumina, Inc.

Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server wit…

Company / brand: Illumina recalls

Official ID Z-0068-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Brand Name recall — Custom Interventional Pain Management, LLC

Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Company / brand: Custom Interventional Pain Management recalls

Official ID Z-0067-2027 · Official record ↗

FDA Class II · Medical device · October 7, 2026