Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 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 1,708 FDA device recalls.

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DateProductReasonClassFirm
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
Apr 29, 2021 Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfu... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Cust... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB8M63R5, Custom Pack BB8M63R5 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 CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System,... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 28, 2021 Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... Class II Medtronic Vascular, Inc.
Apr 27, 2021 Braive Growth Modulation System Break-Off Set Screws - Product Usage: intende... Product is impacted by a thread profile defect due to a manufacturing issue. Class II Medtronic Sofamor Danek USA, Inc
Apr 7, 2021 Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card... The device may contain a manufacturing defect of a missing resistance spot weld (RSW). Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.