Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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Date	Product	Reason	Class	Firm
Oct 28, 2021	Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Numb...	This recall has been initiated to address bulk packed, non-sterile Intravascular Administration S...	Class II	Stradis Medical, LLC dba Stradis Healthcare
Oct 27, 2021	Neuro Convenience Kit	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.	Class II	Medline Industries Inc
Oct 27, 2021	Bedside PICC CDS Convenience Kit	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.	Class II	Medline Industries Inc
Oct 27, 2021	Major Vascular CDS Convenience Kit	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.	Class II	Medline Industries Inc
Oct 27, 2021	Venous Access Pack-LF Convenience Kit	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.	Class II	Medline Industries Inc
Oct 27, 2021	EVLP Convenience Pack/Kit	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.	Class II	Medline Industries Inc
Oct 26, 2021	The product is a handheld ultraviolet-C germicidal wand and contains two, nar...	Excessive ultraviolet-C radiation	Class II	MAX LUX CORP
Oct 25, 2021	Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M...	The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low s...	Class II	Northgate Technologies, Inc.
Oct 25, 2021	Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM...	The labels on the packages of screws were switched.	Class II	Smith & Nephew, Inc.
Oct 25, 2021	MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium I...	Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation o...	Class II	Aesculap Implant Systems LLC
Oct 22, 2021	ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954	Product was shipped from a Medline warehouse to a customer at room temperature instead of refrige...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Oct 22, 2021	Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Re...	If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-en...	Class II	Thoratec Corp.
Oct 22, 2021	The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection...	Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unrea...	Class II	Atrium Medical Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of stricture...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of stricture...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb...	If the system experiences an overvoltage / power surge it can cause a short circuit condition wit...	Class II	Philips North America Llc
Oct 21, 2021	HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I ...	Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi...	Class II	AMO Manufacturing USA, LLC
Oct 21, 2021	CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb...	If the system experiences an overvoltage / power surge it can cause a short circuit condition wit...	Class II	Philips North America Llc
Oct 21, 2021	HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictur...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictur...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	iDesign, Model - G300: System AWS (International), System AWS (China), Advanc...	Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi...	Class II	AMO Manufacturing USA, LLC
Oct 21, 2021	HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strict...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 20, 2021	Artis zee multi-purpose with software VD12-angiography systems developed for ...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q.zen floor with software VD12-angiography systems developed for single...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q ceiling with software VD12-angiography systems developed for single a...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Aspiration Syringe Kit, REF: MVSK60	Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.	Class II	MICROVENTION INC.
Oct 20, 2021	Artis zee biplane with software VD12-angiography systems developed for single...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q.zen biplane with software VD12- angiography systems developed for sin...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number ...	The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stor...	Class II	Biomeme, Inc.
Oct 20, 2021	Artis zee ceiling with software VD12-angiography systems developed for single...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis zee floor with software VD12-angiography systems developed for single a...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q biplane with software VD12-angiography systems developed for single a...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q floor with software VD12- angiography systems developed for single an...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2021	Artis Q.zen ceiling with software VD12-angiography systems developed for sing...	If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2021	Model B35200 - Percept PC BrainSense Implantable Neurostimulator	During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become...	Class II	Medtronic Neuromodulation
Oct 19, 2021	Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Numb...	An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in er...	Class II	InfuTronix LLC
Oct 18, 2021	Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 6...	A potential risk for false negative nitrite results exists when endogenous creatinine levels are ...	Class II	Roche Diagnostics Operations, Inc.
Oct 18, 2021	Total Thyroxine (T4) ELISA; REF EIA-1781	Firm has identified two lots of product that do not meet product shelf life, resulting in failed ...	Class II	DRG International, Inc.
Oct 16, 2021	Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ...	Class II	Western/Scott Fetzer Company
Oct 16, 2021	Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ...	Class II	Western/Scott Fetzer Company
Oct 16, 2021	Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS...	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ...	Class II	Western/Scott Fetzer Company
Oct 16, 2021	Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS...	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ...	Class II	Western/Scott Fetzer Company
Oct 15, 2021	Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Des...	To ensure sterilization effectiveness, sterilization tray instructions for use were updated and n...	Class II	Karl Storz Endoscopy
Oct 15, 2021	Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT E...	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ...	Class II	Medtronic Vascular, Inc.
Oct 15, 2021	GE Centricity Universal Viewer Zero Footprint Client	There is a potential to display incomplete patient imaging study.	Class II	GE Healthcare, LLC
Oct 15, 2021	VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 ...	Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-...	Class III	Ortho-Clinical Diagnostics, Inc.
Oct 15, 2021	Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF...	During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube	Class II	Medtronic Vascular, Inc.

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.