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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
May 29, 2015 Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F... A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class II Tecan US, Inc.
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an... When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d... Class II Siemens Medical Solutions USA, Inc.
May 29, 2015 GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 28, 2015 Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 28, 2015 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable to... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transju... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 28, 2015 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, ... It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to br... Class II Synthes, Inc.
May 28, 2015 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction ... Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an in... Class II Synthes, Inc.
May 28, 2015 Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch... User settings were no longer on the monitor's memory after these systems were powered off and bac... Class II Barco Inc.
May 28, 2015 Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on Endo... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 27, 2015 The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxi... Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centr... Class II Terumo Cardiovascular Systems Corporation
May 27, 2015 RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Br... Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction dista... Class II RAYSEARCH LABORATORIES AB
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt ... Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because t... Class II Integra LifeSciences Corp.
May 27, 2015 PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm... certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0... Class II Synthes, Inc.
May 27, 2015 Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical... Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits becaus... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware v... In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proto... Class II PTW-Freiburg

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.