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
Jul 14, 2022 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... Class II Medtronic Inc.
Jun 24, 2022 Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ... Class II Medtronic Inc
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 27, 2022 LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... Class II Medtronic Neuromodulation
May 23, 2022 MiniMed 630G Insulin Pump (U.S. and Canada Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 620G Insulin Pump (O.U.S. version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 780G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 640G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 720G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 740G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 5, 2022 HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... Class I Medtronic Inc
May 3, 2022 NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
May 3, 2022 NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
Apr 29, 2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Apr 29, 2022 NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Apr 29, 2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Apr 20, 2022 The C304-HIS device features a guide wire to access the vein, a valve to redu... The firm's internal processes identified that certain lots may have an improperly sealed barrier ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 20, 2022 Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. Class II Medtronic Perfusion Systems
Apr 14, 2022 HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... Class I Medtronic Inc
Apr 12, 2022 Cobalt Models loaded with CareLink SmartSync Device Manager application softw... Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 12, 2022 Crome Models loaded with CareLink SmartSync Device Manager application softwa... Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 30, 2022 Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... Class II Medtronic Inc
Mar 30, 2022 Percept BrainSense Implantable Neurostimulator (INS), Model B35200 The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... Class II Medtronic Neuromodulation
Mar 30, 2022 Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... Class II Medtronic Neuromodulation
Mar 30, 2022 Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p... Class II Medtronic Neuromodulation
Mar 25, 2022 Puritan Bennett 980 Series Ventilator The audible alarm may not sound and/or the omni-directional LED visual alarm may not display duri... Class I Medtronic formerly Covidien
Mar 23, 2022 Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 23, 2022 Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 2, 2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... There is potential for the capsule bond to break during the procedure. Class I Medtronic Inc
Feb 28, 2022 MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... There is a software anomaly with the InterStim X Clinician software application with results in t... Class II Medtronic Neuromodulation
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Jan 27, 2022 MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... Class II Medtronic MiniMed
Jan 18, 2022 LINQ II Insertable Cardiac Monitor Devices may lose functionality due to susceptibility to moisture ingress. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 22, 2021 NIM TRIVANTAGE EMG Endotracheal Tube There is potential for multiple issues due to a manufacturing nonconformity. Class II Medtronic Xomed, Inc.
Dec 21, 2021 Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... Class II Medtronic Vascular, Inc.
Dec 15, 2021 Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... Class II Medtronic Xomed, Inc.
Dec 6, 2021 Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1... Reports have been received of tip damage during use of the devices which resulted in some instanc... Class I ev3 Inc.
Dec 6, 2021 Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1... Reports have been received of tip damage during use of the devices which resulted in some instanc... Class I ev3 Inc.
Nov 19, 2021 Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... There have been reports of stent migration. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 19, 2021 Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... Class II Medtronic Sofamor Danek USA Inc
Nov 11, 2021 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... Class I Medtronic Navigation, Inc.
Nov 9, 2021 Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... Class II Medtronic Navigation, 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.