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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

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
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... Class II Biosense Webster, Inc.
May 15, 2017 Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: ... The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 w... Class II Beckman Coulter Inc
May 9, 2017 Access System-Free T4 Assay, B01902E, Catalog No. 33880 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Access Total T3, A34435H, Catalog No. 33830 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Access Thyroglobulin, A34085G, Catalog No. 33860 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 8, 2017 MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 5, 2017 Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagn... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog num... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Spec... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Anal... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage:... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... Class II Alphatec Spine, Inc.
May 5, 2017 CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog nu... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-2... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Ana... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analy... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyt... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 4, 2017 Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and K... Due to possibility of insufficient sterilization. Class II Applied Medical Resources Corp
May 2, 2017 Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly... Class II Implant Direct Sybron Manufacturing, LLC
May 1, 2017 APLIO 300 TUS-A300 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
May 1, 2017 APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic... When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
May 1, 2017 XARIO 100 TUS-X100 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
May 1, 2017 APLIO 500 TUS-A500 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
May 1, 2017 XARIO 200 TUS-X200 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
Apr 26, 2017 Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System... Class I Abbott Vascular
Apr 24, 2017 UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, ... There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... Class II Beckman Coulter Inc.
Apr 24, 2017 UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... Class II Beckman Coulter Inc.
Apr 24, 2017 Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... Class I Respironics California Inc
Apr 24, 2017 Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reage... Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of ... Class II Beckman Coulter Inc.
Apr 20, 2017 VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Ane... Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the revers... Class II Vortran Medical Technology 1, Inc
Apr 20, 2017 VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; ... Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the revers... Class II Vortran Medical Technology 1, Inc
Apr 13, 2017 Access BR Monitor, Part No. 387620 Following biases observed in the results of the French National Quality Controls, Beckman Coulter... Class II Beckman Coulter Inc.
Apr 3, 2017 Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantit... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the qua... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quant... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 ... Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS S... Class II Beckman Coulter Inc.
Apr 3, 2017 Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantit... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for qu... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantit... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 3, 2017 Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended ... Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... Class II Beckman Coulter Inc.
Apr 1, 2017 Healon V, Part No. 10290045 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ... Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon 5 Pro, Part No. 10270015 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)

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.