Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; use...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	Remington MEDICAL Drainage Bag, REF 600-D;	There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.	Class II	Remington Medical, Inc.
Nov 3, 2023	Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura X...	Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023	Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion ...	Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023	STERILE PVP SLN KIT, REF DYNDM1097	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor	It may create the potential for amplified noise and/or overall signal reduction of the ICM, which...	Class II	Medtronic Inc.
Nov 3, 2023	STERILE STERILE PREP STICK, REF DYNDA1134	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	STERILE PVP, REF DYNDA1649	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; us...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used ...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automat...	Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delay...	Class II	Inpeco S.A.
Nov 3, 2023	Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation	The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 ...	Class II	Liberty Medical Solutions, LLC
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	STERILE BETADINE, REF DYNDA1998	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; use...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	STERILE POVIDONE, REF DYNDA2061	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	STERILE PVP SOLUTION, REF DYNDA1907	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used ...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 3, 2023	QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used ...	Nonconforming devices while manufactured correctly, do not comply to their design requirements. ...	Class II	Wilson-Cook Medical Inc.
Nov 2, 2023	Sperm separation media are used to separate motile sperm from other constitue...	The lower layer component of a sperm separation Kit does not match the certificate of analysis. T...	Class II	Fujifilm Irvine Scientific, Inc.
Nov 2, 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01	One product complaint was received reporting that there was an incorrect adapter in the packaging...	Class II	Biomet, Inc.
Nov 2, 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02	One product complaint was received reporting that there was an incorrect adapter in the packaging...	Class II	Biomet, Inc.
Nov 1, 2023	CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562	This recall is being issued due to items within the kit have expired prior to the overall kit exp...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023	LITe Decompression Snake Arm, REF 48080230	Product arm was manufactured with the incorrect clamp component. As a result, the affected produc...	Class II	Stryker Spine
Nov 1, 2023	24 BLOOD CULTURE KIT, REF DYNDH1632	This recall is being issued due to items within the kit have expired prior to the overall kit exp...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023	Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo...	A software issue where "low" and "terminal" battery alerts did not display on the screen to the u...	Class II	Turncare, Inc
Nov 1, 2023	BLOOD CULTURE KIT, REF DYNDH1647B	This recall is being issued due to items within the kit have expired prior to the overall kit exp...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023	PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561	This recall is being issued due to items within the kit have expired prior to the overall kit exp...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023	ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245	This recall is being issued due to items within the kit have expired prior to the overall kit exp...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023	Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu...	In affected products, the tubing outer diameter may vary in size or the length of tubing may be t...	Class I	B. Braun Medical, Inc.
Nov 1, 2023	Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c...	Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share...	Class II	CHANGE HEALTHCARE CANADA COMPANY
Nov 1, 2023	Atrium Oasis Drain Single W / AC, Part No. 3600-100	A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira...	Class II	Atrium Medical Corporation
Oct 31, 2023	Acrobat-i Vacuum Positioner System, Model Number XP-5000Z	The Positioner Arm may not tighten or lock during normal use.	Class II	Maquet Cardiovascular, LLC
Oct 31, 2023	1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M	The organization completed a product improvement process to the conjugate found within the certai...	Class II	Zeus Scientific, Inc.
Oct 31, 2023	HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Mod...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numbe...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G	The organization completed a product improvement process to the conjugate found within the certai...	Class II	Zeus Scientific, Inc.
Oct 31, 2023	The 4Kscore Test, an in vitro serum or plasma test that combines the results ...	Mathematical modeling of the 4Kscore with and without DRE information was recently performed on o...	Class II	BioReference Health, LLC
Oct 31, 2023	PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 31, 2023	PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb...	Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T...	Class II	Heartware, Inc.
Oct 30, 2023	Snapshot NIR, REF: KD204	Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the vie...	Class II	KENT IMAGING, INC.
Oct 30, 2023	Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument se...	Units were not intended for commercial distribution and inadvertently distributed.	Class II	Folsom Metal Products, Inc.
Oct 30, 2023	DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets tha...	Units were not intended for commercial distribution and inadvertently distributed.	Class II	Folsom Metal Products, Inc.
Oct 30, 2023	Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th...	Abbott has received reports of an increase in reactive negative controls and false positive resul...	Class II	Abbott Molecular, Inc.
Oct 27, 2023	vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used wi...	Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator...	Class II	Vyaire Medical

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.