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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

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Sque... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Nee... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and N... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reser... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 8, 2016 Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syr... A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to ... Class II CareFusion 303, Inc.
Aug 8, 2016 UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 6... There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 wher... Class II Beckman Coulter Inc.
Aug 8, 2016 SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis ... Class II Nidek Inc
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 4, 2016 AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C i... Belt clip may become detached causing electronic components to be exposed. Class II AirStrip Technologies, Inc.
Aug 4, 2016 Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System beca... Class II Toshiba American Medical Systems Inc
Aug 4, 2016 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7... Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t... Class II Beckman Coulter 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...
Aug 2, 2016 LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. Class III Alere San Diego, Inc.
Jul 25, 2016 DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI ... Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than t... Class II Microgenics Corporation
Jul 20, 2016 Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instruc... Incorrect drill protocol in the Instructions for Use (IFU) Class II Nobel Biocare Usa Llc
Jul 19, 2016 Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 ... Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software ver... Class II Thermo Finnigan LLC
Jul 18, 2016 BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... Class III Becton, Dickinson and Company, BD Biosciences
Jul 18, 2016 Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert... Internal investigation found the certain lots of MRSA kits have the potential for performance iss... Class II Cepheid
Jul 15, 2016 Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The syste... Topcon discovered an anomaly with titration, only when EpM is turned on during the titration proc... Class II Topcon Medical Laser Systems, Inc
Jul 14, 2016 STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Int... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Sur... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urolo... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The ... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Int... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intu... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 13, 2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... Class II AccessClosure, Inc., A Cardinal Health Company
Jul 12, 2016 Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with... Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain... Class II Resmed Corporation
Jul 11, 2016 Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number ... The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may ... Class II American National Mfg Inc
Jul 11, 2016 Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Str... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 5, 2016 RePlant¿ Angled Abutment Part Number 6050-52-60 Issue with design specification; oversized condition. Class II Implant Direct Sybron Manufacturing, LLC
Jul 5, 2016 AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The Amed... Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may e... Class III Branan Medical Corporation

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.