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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Jan 22, 2016 Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are u... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... Class II Covidien LLC
Jan 22, 2016 Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagn... Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing sample... Class II Sekisui Diagnostics P.E.I. Inc.
Jan 22, 2016 Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Casti... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile so... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soa... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover pack... The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inve... Class II Accuray Incorporated
Jan 22, 2016 Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castil... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile so... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile s... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Cast... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile s... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... Class II Covidien LLC
Jan 22, 2016 Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap t... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castil... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile so... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CS... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... Class II 3M Company - Health Care Business
Jan 22, 2016 Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile ... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CS... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Casti... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile so... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 22, 2016 Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castil... Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... Class II Covidien LLC
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Con... 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were pa... Class II Covidien LLC
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.

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.