Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,602 FDA device recalls in 2020.

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Date	Product	Reason	Class	Firm
Jul 30, 2020	Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Numb...	Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa ...	Class II	Cook Inc.
Jul 30, 2020	AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v...	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol...	Class II	RANDOX LABORATORIES, LTD.
Jul 30, 2020	CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or ...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 30, 2020	CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medicatio...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 30, 2020	AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v...	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol...	Class II	RANDOX LABORATORIES, LTD.
Jul 30, 2020	Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and...	Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after...	Class II	Siemens Medical Solutions USA, Inc
Jul 30, 2020	CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infus...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 30, 2020	CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 30, 2020	KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intrana...	Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treat...	Class II	Cardinal Health 200, LLC
Jul 30, 2020	EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129	Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not...	Class II	Thera Test Laboratories, Inc.
Jul 30, 2020	CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medication...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 30, 2020	Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and ...	Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after...	Class II	Siemens Medical Solutions USA, Inc
Jul 30, 2020	CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or ...	Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi...	Class II	CME America, LLC
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, U...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	RayCare, device is stand-alone software - Product Usage: used to support work...	When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image re...	Class II	RAYSEARCH LABORATORIES AB
Jul 29, 2020	AVANOS MIC-KEY SF Gastrostomy Feeding Tube	Devices had cracked or detached from the feeding tube body	Class II	Avanos Medical, Inc.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only,...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only,...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 29, 2020	PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s...	A degradation defect was found that could lead to holes and donning tears at the folding area aro...	Class II	Cardinal Health 200, LLC
Jul 28, 2020	Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medica...	Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.	Class II	Wright Medical Technology, Inc.
Jul 28, 2020	Control, Calibrator Verified, Triage BNP, Model ALR88755	Product was shipped with refrigeration (ice) instead of frozen (dry ice).	Class II	Medline Industries Inc
Jul 28, 2020	Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright...	Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.	Class II	Wright Medical Technology, Inc.
Jul 28, 2020	BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack	Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are ...	Class II	Becton Dickinson & Company
Jul 27, 2020	Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is ...	Sample leaking from the sleeve covering the needle inside the cannula	Class II	C.A. Greiner & Sohne Gesellschaftmbh
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces	Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.	Class II	Office Depot Inc
Jul 27, 2020	Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual:...	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ...	Class II	Karl Storz Endoscopy
Jul 27, 2020	Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual:...	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ...	Class II	Karl Storz Endoscopy
Jul 27, 2020	Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual:...	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ...	Class II	Karl Storz Endoscopy
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB ...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024	Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F inst...	Class II	Medical Components, Inc dba MedComp
Jul 27, 2020	Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: ...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan)...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual:...	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ...	Class II	Karl Storz Endoscopy
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0...	Potential Endotoxin Contamination	Class II	Datascope Corporation
Jul 27, 2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (...	Potential Endotoxin Contamination	Class II	Datascope Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.