Browse Device Recalls

1,680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,680 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 1,680 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 8, 2021	Medical Device Identification Cards associated with Astra XT DR Implantable p...	The back of some Medical Device Identification Cards provided to patients were printed with an er...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 8, 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Prod...	The back of some Medical Device Identification Cards provided to patients were printed with an er...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 4, 2021	Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
Nov 4, 2021	Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
Nov 4, 2021	Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
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 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	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.
Oct 15, 2021	Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET...	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ...	Class II	Medtronic Vascular, Inc.
Oct 12, 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) us...	The processing of collected episode data may fail due to a software error.	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 12, 2021	Medtronic Custom Perfusion kits, with the following product descriptions and ...	Product is labeled as non-pyrogenic but endotoxin testing was not performed.	Class II	Medtronic Perfusion Systems
Sep 27, 2021	Cardioblate CryoFlex Surgical Ablation Console	There is potential for intermittent electrical connectivity between the console and probe.	Class II	Medtronic Perfusion Systems
Sep 23, 2021	Clinician Programmer Application (CPA) model A610 Clinician Software Application	A software anomaly may occur with the clinician programmer application.	Class II	Medtronic Neuromodulation
Sep 13, 2021	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion...	There was a label mix-up between two model numbers resulting in the incorrect guidewire being con...	Class II	Medtronic Perfusion Systems
Sep 9, 2021	C315-HIS Delivery Catheter	Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Sep 2, 2021	Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N...	Engraving on implants may not match what is listed on the pouch labels.	Class II	Medtronic Sofamor Danek USA Inc
Sep 2, 2021	Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N...	Engraving on implants may not match what is listed on the pouch labels.	Class II	Medtronic Sofamor Danek USA Inc
Aug 31, 2021	Medtronic sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 31, 2021	Medtronic sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 31, 2021	Medtronic Sterile single-use blades that are components of the StraightShot M...	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	Medtronic Xomed, Inc.
Aug 24, 2021	DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only	Potential for a wire protrusion through the left heart vent catheter tip	Class II	Medtronic Perfusion Systems
Aug 24, 2021	DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only	Potential for a wire protrusion through the left heart vent catheter tip	Class II	Medtronic Perfusion Systems
Aug 6, 2021	Medtronic HVAD Pump Implant Kits	There is more force required to slide the driveline cover (boot cover) away from the connector af...	Class II	Heartware, Inc.
Jul 9, 2021	Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) ...	Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing ...	Class II	Medtronic Neuromodulation
Jun 11, 2021	CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D...	Due to reports of actuator separation for various delivery catheter systems. Affected products w...	Class II	Medtronic Heart Valves Division
Jun 11, 2021	CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;	Due to reports of actuator separation for various delivery catheter systems. Affected products w...	Class II	Medtronic Heart Valves Division
Jun 11, 2021	CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;	Due to reports of actuator separation for various delivery catheter systems. Affected products w...	Class II	Medtronic Heart Valves Division
Jun 7, 2021	Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra...	During product complaint investigation, it was determined that during stent graft deployment, the...	Class II	Medtronic Vascular, Inc.
Jun 7, 2021	Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G...	During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th...	Class II	Medtronic Vascular, Inc.
Jun 3, 2021	HeartWare HVAD Implant Kit, REF MCS1705PU	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Driveline Extension Cable, REF 100US	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Implant Kit, REF 1104JP	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Pump Implant Kit, REF 1104	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Pump Implant Kit, REF 1103	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Driveline Extension Cable, REF 100	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Pump Accessories, REF MCS1753AK	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Outflow Graft, REF MCS1725OG	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Pump Implant Kit, REF 1153	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 3, 2021	HeartWare HVAD Pump Implant Kit, REF 1125	Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser...	Class I	Heartware, Inc.
Jun 2, 2021	Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3...	Excess nylon flash on the clip.	Class II	Medtronic Neuromodulation
Jun 1, 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 14, 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ...	Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 4, 2021	Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000...	The component part numbers intended for shipment to a third-party, where they are further process...	Class I	Medtronic Vascular
Apr 29, 2021	Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System,...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Ster...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Ste...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion Sys...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion Syst...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems

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.