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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

4,602 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.

Clear
DateProductReasonClassFirm
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 11, 2014 FlowCOUPLER. An implantable device that is used to detect blood flow in ves... Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... Class II Baxter Healthcare Corporation
Jul 1, 2014 InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagno... Product was distributed without 510(k) approval. Class II Biogenex Laboratories, Inc.
Jun 30, 2014 PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment ... RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility th... Class II Ra Medical Systems Inc
Jun 26, 2014 Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the S... Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that ... Class II Alphatec Spine, Inc.
Jun 25, 2014 Merci Retriever Intended to restore blood flow in the neurovasculature by ... Merci Retrievers were shipped to US customers past their expiration date, even though they were l... Class II Concentric Medical Inc
Jun 25, 2014 Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... The case label correctly states partial rebreather but the insert label incorrectly states non-re... Class II Salter Labs
Jun 25, 2014 Essential NEO, Audio/Visual Integration Unit An audio/visual integration u... KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable cou... Class II Karl Storz Endoscopy
Jun 20, 2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... Class II Stryker Endoscopy
Jun 17, 2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006... CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a... Class II CareFusion 303, Inc.
Jun 17, 2014 C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilog... Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerator... Class II Varian Medical Systems, Inc.
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed Inc.
Jun 16, 2014 Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for us... Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. Class II Nidek Inc
Jun 13, 2014 Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction wi... Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the inst... Class II Intuitive Surgical, Inc.
Jun 12, 2014 WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade ... Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in ... Class II Biolase Technology Inc
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... Laser aperture label was not affixed to device prior to shipment in the US. Class II Nidek Inc
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Sie... The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to altern... Class II Siemens Healthcare Diagnostics Inc.
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: ... Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for... Class II Nidek Inc
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 6, 2014 BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer ... Laser cooling fans and internal fan of the associated fluidics cart are not operational. Class II BD Biosciences, Systems & Reagents
Jun 3, 2014 ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30... There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on ... Class II Siemens Medical Solutions USA, Inc.
Jun 3, 2014 CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201... Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may un... Class II Nihon Kohden America Inc
Jun 2, 2014 EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWri... Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Man... Class II Intuitive Surgical, Inc.
Jun 2, 2014 MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrume... Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becomin... Class II Siemens Healthcare Diagnostics, Inc.
May 30, 2014 Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o... Class III Alere San Diego, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 21, 2014 Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinc... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... 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.