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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

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.

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DateProductReasonClassFirm
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Ite... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 ARTIS one with a hybrid cable- An angiography system developed for diagnostic... Examination room monitor connected with the hybrid cable may have a display issue and no image fu... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Sin... Custom sheath Introducer contains incorrect needle size Class II Merit Medical Systems, Inc.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-20... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... Potential for the spring to become loose and fall out of the device, if the spring falls out duri... Class II Aesculap Implant Systems LLC
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 20, 2023 ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medi... ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. Class II Baxter Healthcare Corporation
Mar 20, 2023 Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... Class II Philips North America
Mar 20, 2023 DERMLITE DL4W, REF: DL4W, Rx Only MD, CE Incorrect labeling; Package labeling contains a different serial number then the serial number on... Class II DermLite LLC
Mar 20, 2023 Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... Class II Philips North America
Mar 17, 2023 Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler... Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers wit... Class II Medtronic Neuromodulation
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Mar 17, 2023 Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ... Class II Philips North America Llc
Mar 17, 2023 CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. ... Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permane... Class II Beaver Visitec International, Inc.
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Mar 16, 2023 JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL... JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disas... Class II SPINEART SA
Mar 16, 2023 ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blad... A portion of the two products were incorrectly marked (etched) and packaged resulting in a produc... Class II Carefusion 2200 Inc
Mar 16, 2023 Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP... When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam i... Class II Ellex Medical Pty Ltd.
Mar 16, 2023 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 15, 2023 Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each... The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples th... Class II Beckman Coulter, Inc.
Mar 14, 2023 HAMILTON-C6, REF: 160021 Software error causes, safety ventilation, in which ventilation continues in the "safety ventilat... Class II Hamilton Medical AG
Mar 14, 2023 ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Cu... Potential shearing of the disposable blade may occur and be contained within the of Flexible Cure... Class II Advanced Research Medical, LLC
Mar 13, 2023 Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to pro... The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would no... Class II Spectrum Medical Ltd.
Mar 10, 2023 PVT Interface Module (PVT)-Laboratory Automation system Brand names of the... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names ... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende... Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produ... Class II Howmedica Osteonics Corp.
Mar 10, 2023 Storage and Retrieval Module (SRM)-Laboratory Automation system Brand name... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 VITROS 5600 Integrated System - Refurbished . For use in the in vitro quanti... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... Sterility; Steril surgical procedure packs contain incomplete seals. Class II Alcon Research, LLC
Mar 10, 2023 VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-qua... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intende... Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produc... Class II Howmedica Osteonics Corp.
Mar 10, 2023 Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.

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.