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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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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

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

Clear
DateProductReasonClassFirm
Mar 15, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... Class I Hospira Inc.
Mar 11, 2013 All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - M... The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead o... Class I Lifescan Inc
Mar 7, 2013 Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s... When using the SERVO-i on battery power, in a very small number of cases, some battery modules di... Class I Maquet Cardiovascular Us Sales, Llc
Mar 6, 2013 Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... The recall was initiated because Carefusion has received reports of a communication error on the ... Class I Carefusion Corporation
Mar 4, 2013 REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ... Class I Medtronic Xomed, Inc.
Feb 27, 2013 Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... Risk that air may be introduced into the device which may lead to an air embolism. Class I Vascular Solutions, Inc.
Feb 25, 2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... Class I Symbios Medical Products, LLC
Feb 8, 2013 Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Feb 8, 2013 Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Feb 6, 2013 Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Re... In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when use... Class I Smiths Medical ASD, Inc.
Jan 18, 2013 St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... Class I St Jude Medical Inc
Jan 15, 2013 Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may caus... Class I Del Mar Reynolds Medical, Ltd.
Jan 8, 2013 Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label... Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ... Class I GE Healthcare, LLC
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 3, 2013 Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indic... Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pu... Class I Animas Corporation
Jan 2, 2013 The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for ... Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective lab... Class I Lumenis Limited
Dec 19, 2012 HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMIL... Analysis of a customer complaint has shown that during ventilation of small pediatric patients wi... Class I Hamilton Medical Inc
Dec 18, 2012 Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t... The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of... Class I Ad-Tech Medical Instrument Corporation
Nov 19, 2012 Patient Circuit used with the Life Pulse High Frequency Ventilator. The Pati... Customer complaints received indicate the heater wire insulation can melt, causing a short which ... Class I Bunnell, Inc.
Nov 19, 2012 Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes... Class I Fisher & Paykel Healthcare, Ltd.
Nov 16, 2012 Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: ... Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwis... Class I Praxair Inc.
Nov 15, 2012 Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2%... Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD a... Class I Bausch and Lomb, Incorporated
Nov 14, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class I B Braun Medical, Inc.
Nov 12, 2012 Zimmer Spine Ardis Inserter, Rx, non-sterile Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when... Class I Zimmer, Inc.
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 8, 2012 ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides ar... With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become awa... Class I Stryker Howmedica Osteonics Corp.
Oct 25, 2012 The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorpor... Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to p... Class I Verathon, Inc.
Oct 15, 2012 Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitat... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 15, 2012 GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Sep 13, 2012 HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to... Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions tha... Class I Heartsine Technologies, Limited
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Bur... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Aug 29, 2012 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 29, 2012 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 23, 2012 Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia b... King Systems received a customer complaint indicating that the customer had ordered a breathing c... Class I King Systems Corp.
Aug 21, 2012 Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*... Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified bl... Class I Vycor Medical, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 13, 2012 Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 13, 2012 Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue related to the carbon d... Class I Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 3, 2012 Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. ... May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a compo... Class I Newport Medical Instruments Inc
Aug 3, 2012 Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: ... Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXI... Class I Ethicon Endo-Surgery Inc
Jul 31, 2012 V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usag... Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ve... Class I Respironics California Inc
Jul 18, 2012 Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers... Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)

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.