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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

4,686 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
Sep 30, 2015 BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a... Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Class III Becton, Dickinson and Company, BD Biosciences
Sep 30, 2015 Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. The C-arm may interfere with the table top under certain circumstances. Class II Shimadzu Medical Systems
Sep 29, 2015 TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they m... Class II Tekia, Inc.
Sep 28, 2015 ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assess... An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessmen... Class II Varian Medical Systems, Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 10, 2015 MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II Beckman Coulter Inc.
Sep 10, 2015 Carto 3 EP Navigation System. Electro physiology system which views of the el... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed... Class II Biosense Webster, Inc.
Sep 10, 2015 MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II Beckman Coulter Inc.
Sep 10, 2015 SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac ... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed... Class II Biosense Webster, Inc.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Sep 8, 2015 Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CM... Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typica... Class II Biocare Medical, LLC
Sep 5, 2015 ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ... Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ... Class II Siemens Medical Solutions USA, Inc.
Sep 4, 2015 EnVision FLEX/HRP visualization reagent found in the following kits: EnVisio... There is a defect in one lot of a buffer, non-specific background staining that has, in some inst... Class II Dako North America Inc.
Sep 4, 2015 -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipe... The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Aug 31, 2015 Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a param... Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectl... Class II Beckman Coulter Inc.
Aug 27, 2015 CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Class III Becton, Dickinson and Company, BD Biosciences
Aug 27, 2015 Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u... Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned c... Class III Alere San Diego, Inc.
Aug 21, 2015 Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with th... Overheating and burning of the wire insulation inside the applicator. Class II DJO, LLC
Aug 19, 2015 Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... One Distal Access Catheter intended for distribution in Korea, was found at a US location. Class II Concentric Medical Inc
Aug 19, 2015 ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... Class II Siemens Medical Solutions USA, Inc.
Aug 18, 2015 Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid... Some devices exhibit backup VVI operation due to a backup reset. Class II St Jude Medical Cardiac Rhythm Management Division
Aug 17, 2015 da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 ... Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System ... Class II Intuitive Surgical, Inc.
Aug 14, 2015 INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose m... Class II Toshiba American Medical Systems Inc
Aug 12, 2015 FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... Class III Abbott Electrophysiology
Aug 10, 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reproc... Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the... Class II Advanced Sterilization Products
Aug 8, 2015 Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Mo... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model num... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Mode... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS300... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model n... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model nu... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 4, 2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebuli... The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or ... Class II Salter Labs
Jul 31, 2015 Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Ap... Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power... Class II Applied Medical Resources Corp
Jul 31, 2015 Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. ... Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restr... Class II Edward Lifesciences, Llc
Jul 30, 2015 AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 28, 2015 Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For t... Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit gr... Class II Beckman Coulter Inc.
Jul 27, 2015 Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi... Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... Class III Cepheid
Jul 27, 2015 Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N... Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... Class III Cepheid
Jul 27, 2015 CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution becaus... Class II Advanced Sterilization Products
Jul 27, 2015 Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Jul 27, 2015 Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Jul 22, 2015 COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. ... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 22, 2015 COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the abil... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 22, 2015 Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... Class II Medtronic MiniMed 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.