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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,730 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,730 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 1,730 FDA device recalls.

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DateProductReasonClassFirm
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm D... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 28, 2016 Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dis... Product sterility compromised due to breach of sterile barrier Class II Medtronic Advanced Energy, LLC
Dec 23, 2016 BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... Class II Becton Dickinson & Company
Dec 12, 2016 AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG... Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Pr... Class II Medtronic Navigation, Inc.
Dec 9, 2016 Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... During internal testing conducted as part of next generation product development, it was discover... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Nov 16, 2016 Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio... Class II Medtronic Inc
Nov 10, 2016 ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... Class II Medtronic Inc
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 4, 2016 Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Oct 4, 2016 Best Practices kits containing certain production lots of Clearify Visualizat... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Oct 3, 2016 Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h... Medtronic has identified an increased number of complaints from customers involving reports of Re... Class II Medtronic Neuromodulation
Oct 3, 2016 Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... Class I Medtronic Neuromodulation
Sep 22, 2016 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate... Class II Medtronic Navigation, Inc.-Littleton
Sep 1, 2016 Visualase Body Accessory Kit PN 020-3000. The individual components within th... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Sep 1, 2016 Visualase Visualization Stylets PN 020-2301. The individual components within... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 5, 2016 CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... Class II Medtronic Inc.
Aug 3, 2016 Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-... Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Jul 18, 2016 MACH Cranial Treon. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 MACH AxiEM Cranial Treon. The software application is sent in CD format with ... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, ... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee repl... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY:... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 Synergy Spine. The software application is sent in CD format with an IFU, wra... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 Fusion ENT Application. The software application is sent in CD format with an... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orth... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, ... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 Synergy Cranial S7. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 FrameLink. The software application is sent in CD format with an IFU, wrapped... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R,... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 S7 MACH FrameLink. The software application is sent in CD format with an IFU,... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee repl... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orth... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic

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.