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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

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

Clear
DateProductReasonClassFirm
Oct 9, 2023 Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccess... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 MED-810A Zemits NDPrime Laser products Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product ... Class II Advance-Esthetic LLC
Oct 9, 2023 Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of u... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), E... Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... Class II Philips Ultrasound, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 6, 2023 ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot... Users of the patient positioning system ORION System can be faced with a sudden short-term accele... Class II LEONI CIA CABLE SYSTEMS
Oct 6, 2023 CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite... Class II Young Dental Manufacturing I, LLC
Oct 6, 2023 D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. The applier did not ... Class II Peter Lazic Gmbh
Oct 6, 2023 D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. The applier did not ... Class II Peter Lazic Gmbh
Oct 6, 2023 Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm There is the potential for the needle drive to become dislodged and/or broken which could result ... Class II Intuitive Surgical, Inc.
Oct 6, 2023 ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot... Users of the patient positioning system ORION System can be faced with a sudden short-term accele... Class II LEONI CIA CABLE SYSTEMS
Oct 6, 2023 D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. The applier did not ... Class II Peter Lazic Gmbh
Oct 5, 2023 MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00;... If "Clear All" selected medications is selected on patient profile, the automated dispensing cabi... Class II CareFusion 303, Inc.
Oct 5, 2023 Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... Mislabeling Class II Encore Medical, LP
Oct 5, 2023 Mobilett Mira wireless (VA20) mobile x-ray system(s) Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray a... Class II Siemens Medical Solutions USA, Inc
Oct 5, 2023 REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Mislabeling Class II Encore Medical, LP
Oct 4, 2023 CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used fo... Potential for damaged and frayed power connector plug with repeated bending or manipulation beyon... Class II St. Jude Medical
Oct 4, 2023 Zenition 50 & 70 Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 AT HOME MARIJUANA TEST STRIP, SKU 900752 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU ... Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 ORAL B MOUTH SORE RINSE 237ML, SKU 999087 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 Azurion IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 Integris-Allura IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 VERIQUICK PREGNANCY TEST 1CT, SKU 901260 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic... Due to products distributed without premarket clearance or approvals. Class II Visgeneer, Inc.
Oct 4, 2023 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Veradius Unity Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000... Progressa+ beds have the potential for static buildup from the casters and/or power drive. This s... Class II Baxter Healthcare Corporation
Oct 4, 2023 BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20G... Over-the-needle, intravascular catheters may have needles that do not retract properly into the b... Class II Becton Dickinson Infusion Therapy Systems Inc.
Oct 4, 2023 MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic... Due to products distributed without premarket clearance or approvals. Class II Visgeneer, Inc.
Oct 4, 2023 DENTEMP ONE STEP .077OZ, SKU 902139 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Allura Xper IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 FIRST RESPONSE 2 CT, SKU 902343 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.

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.