Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

Clear
DateProductReasonClassFirm
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
Dec 22, 2017 ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume I... 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) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2... 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 CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-428... 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) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) ... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 11, 2017 Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels p... Product sterility potentially compromised. Class II Medical Action Industries Inc
Nov 9, 2017 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Nov 3, 2017 ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... Contact lenses lack sterility assurance. Class II Alden Optical
Oct 23, 2017 Surgical punch; sealed pouches packed in punch shelf box Intended for use... Surgical punches are being recalled due to potential packaging damage which may have occurred dur... Class II Alto Development 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.