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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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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.

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DateProductReasonClassFirm
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WIT... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog... Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of t... Class II Pega Medical Inc.
Feb 20, 2015 Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - Internat... Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parame... Class II Optimedica Corporation
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008T with the following product code and ... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured... The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that ... Class II TITAN SPINE, LLC
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K2 with the following product code and... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K with the following product code and ... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and C... Device may experience loss of suction during treatment resulting in scoring the cornea during len... Class II Abbott Medical Optics, Inc.
Feb 19, 2015 ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... Class III Arc Medical Inc
Feb 19, 2015 Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ... Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri... Class II Steris Corporation
Feb 19, 2015 AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small... STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will ... Class II Steris Corporation
Feb 19, 2015 Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... Class III Richard-Allan Scientific Company
Feb 19, 2015 BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #3... Becton Dickinson received an elevated number of complaints for blood or infusate/medication leaka... Class II Becton Dickinson & Company
Feb 18, 2015 The Spirit TM Select bed is a Med-Surg bed intended to support and transport ... It was identified that in some situations the bed exit alarm may not function as intended. The so... Class II CHG Hospital Beds Inc
Feb 18, 2015 Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to... Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/re... Class II Siemens Medical Solutions USA, Inc
Feb 17, 2015 Double Swivel Connector with Suction Port Connector, Airway (Extension) Kin... Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel ... Class II King Systems Corp.
Feb 17, 2015 EOS, Digital radiography system used in general radiographic examinations. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be... Class II Eos Imaging Inc
Feb 17, 2015 Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femora... For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead ... Class II Synthes, Inc.
Feb 17, 2015 Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable ... The company has received reports of structural non conformance at the connection between the valv... Class II US Endoscopy Group Inc
Feb 17, 2015 Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemod... Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condit... Class II Transonic Systems Inc
Feb 16, 2015 GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbe... Potential safety issue due to improper assembly associated with the power cords of T2100 and T200... Class II GE Healthcare
Feb 16, 2015 ExacTrac versions 6.x patient positioning systems are used to position patien... The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the E... Class II Brainlab AG
Feb 16, 2015 Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D... Locking pegs were not locking during distal radius procedures. There has been one (1) report of r... Class II Flower Orthopedics Corporation
Feb 16, 2015 Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000)... There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have... Class II Intuitive Surgical, Inc.
Feb 13, 2015 Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 1... Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not f... Class II Aaren Scientific, Incorporated
Feb 13, 2015 Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic... Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed... Class II Exactech, Inc.
Feb 13, 2015 - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio ... The firm is recalling sterile enteral feeding syringes due to determining that the sterility of t... Class II Medela Inc. EF Division
Feb 12, 2015 Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autost... A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopc... Class II Dako North America Inc.
Feb 12, 2015 Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Dist... Potential for weld disassociation of the cross pin, which could lead to loose or disassociated tr... Class II Stryker Howmedica Osteonics Corp.
Feb 12, 2015 Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouche... Devices were not sterilized Class II Ameda, Inc.
Feb 12, 2015 Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primar... Devices were not sterilized Class II Ameda, Inc.
Feb 11, 2015 Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pou... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Sin... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Techno... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouc... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar,... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Versio... Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1... Class II Siemens Healthcare Diagnostics, Inc.
Feb 11, 2015 Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Myl... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with th... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Feb 11, 2015 Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services 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.