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.

Date	Product	Reason	Class	Firm
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Conf...	System does not trigger a cancel command followed by a reload of the scan with the new parameter(...	Class II	Siemens Medical Solutions USA, Inc
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Us...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immun...	Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient s...	Class II	Diasorin Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	APEX Compounding System Control Panel Module, REF: 601238, Product Code AX100...	There is the potential for the compounding system to not immediately interrupt compounding and al...	Class II	B Braun Medical, Inc.
Nov 23, 2020	Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product U...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric...	During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically ...	Class II	Roche Diagnostics Operations, Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3...	May contain a damaged internal component which could impede staple deployment and result in incom...	Class II	Covidien Llc
Nov 23, 2020	Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Us...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871...	When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t...	Class II	Roche Molecular Systems, Inc.
Nov 23, 2020	Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	APEX Compounding System Control Panel Module, REF: 601224, Product Code AX100...	There is the potential for the compounding system to not immediately interrupt compounding and al...	Class II	B Braun Medical, Inc.
Nov 23, 2020	ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro ...	Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vit...	Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 23, 2020	Revolution CT with Apex Edition CT System - Product Usage: intended for head,...	A potential for protocol(s) with unintended patient orientation or scan setting when using Intel...	Class II	GE Healthcare, LLC
Nov 23, 2020	Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m...	May contain a damaged internal component which could impede staple deployment and result in incom...	Class II	Covidien Llc
Nov 23, 2020	APEX Compounding System Control Panel Module, REF: 601237, Product Code AX100...	There is the potential for the compounding system to not immediately interrupt compounding and al...	Class II	B Braun Medical, Inc.
Nov 23, 2020	Revolution CT ES - Product Usage: intended for head, whole body, cardiac and ...	A potential for protocol(s) with unintended patient orientation or scan setting when using Intell...	Class II	GE Healthcare, LLC
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 23, 2020	Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product ...	The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 20, 2020	Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref ...	Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered b...	Class II	Haag-Streit USA Inc
Nov 20, 2020	HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020	VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product...	A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may...	Class II	Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020	Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin c...	Device has the potential for fracture during use.	Class II	Zimmer Biomet, Inc.
Nov 20, 2020	HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020	enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ...	A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may...	Class II	Ortho-Clinical Diagnostics, Inc.
Nov 19, 2020	DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical...	RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react...	Class II	Synthes (USA) Products LLC

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.