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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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DateProductReasonClassFirm
Apr 16, 2024 COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Mar 28, 2024 Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator inability to reprogram one device Class II Medtronic Neuromodulation
Mar 26, 2024 Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... Class I Medtronic Navigation, Inc.
Mar 19, 2024 Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Clearview Blower/Mister, Model Number 22120 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Feb 16, 2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... There is a potential for sterile package breach. Class II Medtronic Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 9, 2024 Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... Class II Covidien
Jan 9, 2024 Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... Class II Covidien
Dec 19, 2023 Model A710 Intellis Clinician Programmer Application, version 2.0.97 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ... Class II Medtronic Neuromodulation
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Nov 28, 2023 Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, Inc.
Nov 28, 2023 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, Inc.
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 15, 2023 Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3... Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.... Class II Medtronic MiniMed, Inc.
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-40, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-20, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 7, 2023 NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822... Firm received reports of customers experiencing noise from the NIM System, lead-off or high imped... Class II Medtronic Xomed, Inc.
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.
Oct 19, 2023 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... Units distributed in Korea and Turkey that did not have the correct firmware installed to support... Class II Medtronic Neuromodulation
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Sep 27, 2023 StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... Due to a software anomaly which potentially could result in the surgical planning data shifting t... Class I Medtronic Navigation, Inc.
Sep 26, 2023 Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA 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.