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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

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Mar 31, 2021 HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX49... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the d... The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... Class II Smiths Medical ASD Inc.
Mar 31, 2021 Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and in... Software showing wrong results reported, PDF not match HIS. Class II Soft Computer Consultants, Inc.
Mar 31, 2021 Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids.... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 AM12M Acquisition Module accessory. Impacted software version of the AM12M i... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Mo... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitorin... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Nu... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 Left Heart Kit, Model Number M20268. for blood pressure monitoring. Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 31, 2021 Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 12... Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... Class II Smiths Medical ASD Inc.
Mar 30, 2021 Omnia Soft Tissue Punch is a dental instrument designed to remove with precis... Omnia SRL received a notification from the contract manufacturer informing them of inadequate ste... Class II Omnia SRL
Mar 30, 2021 Artis systems - Product Usage: an angiography systems developed for single an... Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts whic... Class II Siemens Medical Solutions USA, Inc
Mar 29, 2021 AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surg... 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery Class II Musculoskeletal Transplant Foundation, Inc.
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... Class II Philips North America Llc
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intende... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catal... Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across ... Class II Randox Laboratories Ltd.
Mar 29, 2021 Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use hea... Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive cou... Class II Atos Medical AB
Mar 29, 2021 VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blu... VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw vo... Class II Greiner Bio-One North America, Inc.
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product U... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Mar 26, 2021 Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 100... Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of t... Class II Siemens Medical Solutions USA, Inc
Mar 26, 2021 PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to ... Class II Radiometer Medical ApS
Mar 26, 2021 INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
Mar 26, 2021 Regard Dressing Change Tray ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicato... Class II ROi CPS LLC
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Us... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Mar 26, 2021 The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont... An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal... Class II Boston Scientific Corporation
Mar 26, 2021 VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black R... Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly l... Class II Ortho-Clinical Diagnostics, INc.
Mar 26, 2021 Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair wit... Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I Infusion Pump Repair
Mar 26, 2021 KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibi... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
Mar 25, 2021 ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-D... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spin... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic /... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orth... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... Class II Bard Peripheral Vascular 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.