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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

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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
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jun 28, 2016 NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St... Wire in tubing can become exposed, posing potential harm to the intubated patient. Class II Medtronic Xomed, Inc.
Jun 23, 2016 DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 6400... Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Mod... Class II Medtronic Neuromodulation
Jun 20, 2016 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control ... Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because o... Class II Medtronic Navigation
Jun 16, 2016 Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Cat... This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding pr... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jun 10, 2016 Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S000... Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from t... Class II Medtronic Neuromodulation
Jun 6, 2016 Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
May 26, 2016 Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
May 23, 2016 EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethyl... Medtronic is issuing a medical device recall to return product potentially associated with an out... Class II Ev3, Inc.
May 13, 2016 Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number:... Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a pot... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
May 9, 2016 Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists ... Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during proc... Class II Medtronic Navigation, Inc.
May 3, 2016 Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod... Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ... Class II Medtronic Neuromodulation
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... Class I Medtronic
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLin... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Mar 21, 2016 Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom conven... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 General Surgery Pack, part number 006880-3. This is a custom convenience sur... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenien... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 17, 2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,... It has been discovered that replacement x-ray generator and system motion batteries could become ... Class II Medtronic Navigation, Inc.-Littleton
Mar 17, 2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in response to an inter... Class II Medtronic Navigation, Inc.-Littleton
Feb 23, 2016 Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneo... Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" P... Class II Covidien Medical Products (Shanghai) Manufactur...
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic Inc.
Feb 22, 2016 BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile i... Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed ... Class II Medtronic Navigation, Inc.
Feb 19, 2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... Class II Medtronic MiniMed Inc.
Feb 9, 2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... Class II Medtronic Neuromodulation
Feb 4, 2016 Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... Class III Medtronic Perfusion Systems
Jan 29, 2016 Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2... Screws holding the detector panel in as a result the detector panel could make contact with othe... Class II Medtronic Navigation, Inc.
Jan 15, 2016 Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Dec 2, 2015 Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Best Practice Kits containing certain production lots of Endo GIA Ultra Unive... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Nov 9, 2015 Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... Class II Medtronic Inc.
Oct 28, 2015 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... Class II Medtronic Perfusion Systems
Oct 23, 2015 Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A... Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter hav... Class II Medtronic Vascular, Inc.
Oct 21, 2015 Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used... The wire pass hole is not present on the tools. Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 15, 2015 Medtronic Medical Device Identification Card for SureScan pacemaker patients.... Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Sep 14, 2015 P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024... Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d... Class II Medtronic Navigation, Inc.
Sep 14, 2015 P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVE... Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d... Class II Medtronic Navigation, Inc.
Sep 1, 2015 Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... An issue with a USB memory component contained within a subset of CryoConsoles can result in exte... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Aug 27, 2015 Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... Class II Arrow International 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.