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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

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

Clear
DateProductReasonClassFirm
Aug 1, 2024 AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 BD Phoenix M50 instrument -Intended for the rapid identification (ID) and ant... Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix"... Class II Becton Dickinson & Co.
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered an... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered an... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covere... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Aug 1, 2024 WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (P... WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... Class II Boston Scientific Corporation
Jul 31, 2024 Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 During the manufacturing process the devices were laser-marked with the incorrect part number. Class II CooperSurgical, Inc.
Jul 31, 2024 MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway St... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 31, 2024 Stainless Steel Sims Uterine Sound, Part Number 64-601 During the manufacturing process the devices were laser-marked with the incorrect part number. Class II CooperSurgical, Inc.
Jul 31, 2024 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM... Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU Class II Beckman Coulter Inc.
Jul 31, 2024 Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper A... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 31, 2024 MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 30, 2024 Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Mater... During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) ... Class II Siemens Healthcare Diagnostics, Inc.
Jul 29, 2024 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material ... The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... Class II Siemens Healthcare Diagnostics, Inc.
Jul 29, 2024 DR 800. Digital Radiography X-ray System. Potential for the front lever chain of the DR 800 table to fail. Class II Agfa N.V.
Jul 29, 2024 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Numb... The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... Class II Siemens Healthcare Diagnostics, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative m... Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... Class II Siemens Healthcare Diagnostics, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, Inc.
Jul 26, 2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... Class II Beaver Visitec International, 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.