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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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Browse Device Recalls

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Apr 11, 2018 Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Extension Line Slide Clamps; Product codes: SA-09847 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Arterial Catheterization Kit; Product Code:NA-04550-1A Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheter... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Radial Arterial Access Kit; Product Code: ASK-04001-BID2 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Epidural Needle; Product Codes: AN-05501 and AN-05505 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes:... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Codes: ASK-00001-1A Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Shea... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Cathet... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Code: ASK-04000-HMC Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Feb 28, 2018 PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 15, 2018 Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT101... The sterility of the device cannot be assured. There is a potential for an increased risk of infe... Class II Transonic Systems Inc
Jan 31, 2018 StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)0082... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)008270025... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)108... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UD... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 11, 2018 ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, ... Sterility failure found in one of the units in the lot. Class II Ellex iScience, Inc.
Dec 22, 2017 Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbe... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Numbe... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arteria... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-2430... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part ... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use wi... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow 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.