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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

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
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)
Apr 1, 2017 Healon Pro, Part No. 10270012 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 GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Mar 31, 2017 da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... Class II Intuitive Surgical, Inc.
Mar 30, 2017 Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... Class I Newport Medical Instruments Inc
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products ar... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... Class I Thoratec Corporation
Mar 30, 2017 AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... Class II Abbott Medical Optics Inc. (AMO)
Mar 30, 2017 Dressing Rect L, P/N 02428 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr, P/N 04908 Product Usage: These products are sterile dress... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... Class II Siemens Medical Solutions USA, Inc.
Mar 30, 2017 Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Back, P/N 09810 Product Usage: These products are sterile dressi... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dr... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 29, 2017 Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Mar 29, 2017 Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Prod... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Mar 28, 2017 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frame... Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construc... Class II Mizuho OSI
Mar 23, 2017 Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is in... It was discovered during a procedure that when the operator made an exposure on the wireless x-ra... Class II Toshiba American Medical Systems
Mar 22, 2017 Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065... ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detac... Class I ReFlow Medical
Mar 22, 2017 NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 22, 2017 NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 22, 2017 NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... Class I Abbott Vascular
Mar 20, 2017 Tapered SwissPlus Implant System, Model No. SPB10 It was manufactured with the minor diameter of the internal thread that is below specification. Class II Zimmer Dental Inc
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Mo... The issue was identified as a firmware problem with the generator. Class II Toshiba American Medical Systems Inc
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, 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.