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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Nov 7, 2016 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6... Firm received reports about "acquisition errors" and the deterioration of material covering the a... Class II Siemens Medical Solutions USA, Inc.
Nov 4, 2016 MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool ... The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection... Class II Thayer Intellectual Property, Inc.
Nov 1, 2016 Alaris System PC unit, model no. 8000 and 8015. The central programming, mon... Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef... Class II CareFusion 303, Inc.
Oct 25, 2016 Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system wit... Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been ... Class II Toshiba American Medical Systems Inc
Oct 25, 2016 MicroScan LabPro Data Management System. Intended to manage both microbial... Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior whe... Class II Beckman Coulter Inc.
Oct 24, 2016 Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access O... Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... Class II Beckman Coulter Inc.
Oct 24, 2016 Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The A... Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not... Class II Beckman Coulter Inc.
Oct 19, 2016 AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing ... Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased gene... Class II Beckman Coulter Inc.
Oct 14, 2016 ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog... ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak o... Class II Reshape Medical Inc
Oct 12, 2016 Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the p... Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Val... Class II Alere San Diego, Inc.
Oct 10, 2016 Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 6, 2016 The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... Class II AccessClosure, Inc., A Cardinal Health Company
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Us... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... Class II Alphatec Spine, Inc.
Oct 5, 2016 Alligator Retrieval Device The device is intended for use in the peripheral ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;... Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can resu... Class II Intuitive Surgical, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Card... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. ... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Ca... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 1, 2016 4205 Journey Rolling Walker Product Usage: used to assist people in walking Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black si... Class II Nova Ortho-Med Inc
Sep 29, 2016 FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is inten... A complaint was received on September 27th, 2016 at a medical center in Germany for delamination ... Class I SentreHeart Inc
Sep 27, 2016 SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 460... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Tr... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringe... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4259... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposab... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 460... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, 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.