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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
Apr 4, 2016 Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart... Use of the software may show an incorrect value to the user when viewing the Fractional Flow Rese... Class II Merge Healthcare, Inc.
Apr 4, 2016 Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS,... The system will completely stop allowing the downloading or acquisition of new images due to inco... Class II Merge Healthcare, Inc.
Apr 1, 2016 SOMATOM Force, Computed Tomography x-ray system intended to generate and ... The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly l... Class II Siemens Medical Solutions USA, Inc
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Apr 1, 2016 Various trauma and sports medicine instruments and implants. guide, surgical... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Bit, drill. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Passer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Pin, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Appliance, fixa... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Fastener, fixat... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... Class II Philips Medical Systems (Cleveland) Inc
Apr 1, 2016 Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... Class II Philips Medical Systems (Cleveland) Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Plate, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Reamer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Direct Drive Clip Applier CA090, indicated for ligation of tubular structures... Increased customer complaints indicating inconsistent clip application; may lead to unoccluded ve... Class II Applied Medical Resources Corp
Apr 1, 2016 Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU Reports of failure of the device's power supply. Class II Fujifilm Medical Systems U.S.A., Inc.
Apr 1, 2016 Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... Class II Philips Medical Systems (Cleveland) Inc
Apr 1, 2016 Various trauma and sports medicine instruments and implants. cannula, surgic... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Orthopedic manu... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Arthroscope. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Screw, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Spinal interlam... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Rod, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Mar 31, 2016 Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray h... Report of unintentional movement of table to reverse tilting. Class II Shimadzu Medical Systems
Mar 31, 2016 American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgi... Product packaging defective compromising sterility Class II American Surgical Company

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.