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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Jun 23, 2014 BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 Cordis EMPIRA NC RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... Class II Cordis Corporation
Jun 23, 2014 BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 3... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 P... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 20, 2014 Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Mode... Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration Class II ORIGIO, Inc
Jun 20, 2014 Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro ... Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non... Class II ITC-Nexus Dx
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 20, 2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... Class II Stryker Endoscopy
Jun 19, 2014 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Han... Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 569440... Class II Abbott Molecular
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads ... Class II Boston Scientific CRM Corp
Jun 18, 2014 Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.0... With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely... Class II Spacelabs Healthcare Inc
Jun 18, 2014 GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: ... When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to ... Class II Philips Medical Systems (Cleveland) Inc
Jun 17, 2014 Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN... Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo... Class II Siemens Medical Solutions USA, Inc
Jun 17, 2014 Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System ... An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... Class II Terumo Cardiovascular Systems Corporation
Jun 17, 2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006... CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a... Class II CareFusion 303, Inc.
Jun 17, 2014 Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System ... An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... Class II Terumo Cardiovascular Systems Corporation
Jun 17, 2014 C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilog... Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerator... Class II Varian Medical Systems, Inc.
Jun 17, 2014 Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... Inadequate iodine and packaging related defects. Class II Baxter Healthcare Corp.
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed Inc.
Jun 16, 2014 Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for us... Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. Class II Nidek Inc
Jun 15, 2014 Paragon Laboratory Management For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 201... Class II McKesson Technologies, Inc.
Jun 13, 2014 Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction wi... Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the inst... Class II Intuitive Surgical, Inc.
Jun 13, 2014 Titan T 5K Motor Product Usage: Low-speed motor is used with various att... The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded i... Class II Dental EZ Group Star Dental Division
Jun 13, 2014 GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PD... Class II GE Healthcare, LLC
Jun 13, 2014 Ingenia 1.5T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... Class II Aesculap, Inc.
Jun 13, 2014 Ingenia 1.5T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 12, 2014 McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREA... Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 we... Class II Zimmer Manufacturing B.V.
Jun 12, 2014 EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope... Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory... Class II Pentax Medical Company
Jun 12, 2014 Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350... A small number of sealed foil pouches containing the electrodes were found to be difficult to ope... Class II Heartsine Technologies, Limited
Jun 12, 2014 Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade ... Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in ... Class II Biolase Technology Inc
Jun 11, 2014 Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Asse... Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the p... Class II Hospira Inc.
Jun 11, 2014 Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aero... Bottles did not provide positive signals within the time frame of the quality control specificati... Class II Remel Inc
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.
Jun 11, 2014 Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. F... Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could... Class II Medtronic Neuromodulation
Jun 11, 2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... Lack of Sterility Assurance Class II PIONEER SURGICAL TECHNOLOGY, INC.
Jun 11, 2014 IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Int... In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... Class II Intuitive Surgical, Inc.

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.