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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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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
Mar 31, 2016 American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage... 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: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucou... One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% differenc... Class II Becton, Dickinson and Company, BD Biosciences
Mar 31, 2016 American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 E.cam or Symbia systems that use foresight detectors - Product Usage: To dete... E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may los... Class II Siemens Medical Solutions USA, Inc.
Mar 31, 2016 American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude Medical Inc.
Mar 31, 2016 American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 30, 2016 ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... Class III Siemens Healthcare Diagnostics, Inc.
Mar 30, 2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./... The product lot did not meet sterility requirements based on FDA sampling and analysis. Class II Amd-Ritmed, Inc.
Mar 30, 2016 Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08... The label on the Tyvek bag is missing. This is used by customers to identify material code, lot ... Class II Teleflex Medical
Mar 30, 2016 reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product ... Incorrect Power Supply in the package, rendering the device inoperable. Class II LED Technologies, LLC
Mar 29, 2016 Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Mo... Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible ... Class II Ad-Tech Medical Instrument Corporation
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Mar 28, 2016 Merge Cardio software. Product Usage: Merge Cardio is a system intended... If a reader selects Multi-study review prior to the original study completing its loading process... Class II Merge Healthcare, Inc.
Mar 28, 2016 Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, s... Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure coul... Class II Skytron, Div. The KMW Group, Inc
Mar 28, 2016 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar C... Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with L... Class II Becton Dickinson & Co.
Mar 28, 2016 ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Par... Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa... Class II The Anspach Effort, Inc.
Mar 28, 2016 Merge Cardio software. Merge Cardio is a system intended to be used to ac... If images are sent without an order in the system, they will be matched with the latest order on ... Class II Merge Healthcare, Inc.
Mar 28, 2016 Merge PACS software. Merge PACS (Picture Archiving Communication System) ... Cut lines on the image may present horizontally rather than vertically. Class II Merge Healthcare, Inc.
Mar 28, 2016 PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; H... When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inle... Class II Stryker Endoscopy
Mar 28, 2016 Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and ... Eye Station images were not importing properly and were imported under "unknown" due to an issue ... Class II Merge Healthcare, Inc.
Mar 28, 2016 Merge PACS software. Product Usage: Merge PACS (Picture Archiving Commu... The software did not show unviewed images when the last view was skipped. The physician may poten... Class II Merge Healthcare, Inc.
Mar 28, 2016 The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used... Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), wh... Class II Spacelabs Healthcare Inc
Mar 28, 2016 EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, ... The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound Syst... Class II Philips Ultrasound, Inc.
Mar 28, 2016 Merge Hemo software. Merge Hemo monitors, measures, and records physiologic ... There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo... Class II Merge Healthcare, Inc.
Mar 28, 2016 ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Par... Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa... Class II The Anspach Effort, Inc.
Mar 28, 2016 Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Co... Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix ... Class II Boston Scientific Corporation

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.