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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
Jan 27, 2014 syngo Dynamics Picture Archiving and Communication System (PACS). Model num... Potential patient data mixup. Improper error handling could allow for two different patients to ... Class II Siemens Medical Solutions USA, Inc
Jan 27, 2014 Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade an... Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. Class II Synthes, Inc.
Jan 27, 2014 Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillo... One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored b... Class II Synthes, Inc.
Jan 27, 2014 Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synt... Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distribu... Class II Synthes, Inc.
Jan 24, 2014 LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packa... The product may contain high levels of microbial contamination Class II Remel Inc
Jan 24, 2014 NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Cont... NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC ... Class II Hologic, Inc
Jan 24, 2014 Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Jan 24, 2014 Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medic... Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6... Class II Clarity Medical Systems Inc
Jan 24, 2014 Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 53... Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... Class II Carestream Health Inc.
Jan 24, 2014 Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- ... Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... Class II Carestream Health Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Jan 23, 2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class II Atricure Inc
Jan 23, 2014 Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, ... Inner spherical radius of the shell is undersized. Class II Smith & Nephew Inc
Jan 22, 2014 Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxi... Integra LifeSciences has identified through an investigation of complaints that there may be the ... Class II Integra LifeSciences Corp.
Jan 22, 2014 SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ... CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec... Class II CareFusion 303, Inc.
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
Jan 21, 2014 Buzzaround XL scooters' Product Usage: mobility Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possibl... Class II Golden Technologies, Inc.
Jan 20, 2014 Crimper Model 9100CR26 The Crimper is indicated for use in preparing the E... Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper b... Class II Edwards Lifesciences, LLC
Jan 20, 2014 ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX... HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running t... Class II Horiba Instruments, Inc dba Horiba Medical
Jan 20, 2014 GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital ... GE Healthcare has recently become aware of a software issue associated with patient selection fro... Class II GE Healthcare, LLC
Jan 17, 2014 MEDITECH Microbiology - Calculator/data processing module, for clinical use. Potential for patient results being removed from LAB/EMR. Class II Medical Information Technology, Inc.
Jan 16, 2014 Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, mod... CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they m... Class II CareFusion 303, Inc.
Jan 16, 2014 LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System... Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems b... Class II Zest Anchors LLC
Jan 16, 2014 DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Onl... Three lots of circumcision clamps were manufactured out of specification and as a result may not ... Class II DeRoyal Industries Inc
Jan 15, 2014 VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL... Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin... Class III Ortho-Clinical Diagnostics
Jan 14, 2014 The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Ma... Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013... Class II Instrumentarium Dental, PaloDEx Group Oy
Jan 13, 2014 Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyval... Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting asse... Class II Accuray Incorporated
Jan 13, 2014 InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V... Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an ina... Class II Philips Healthcare
Jan 10, 2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... Product does not function as intended up to the expiry date on the product labeling. There is a ... Class II Leica Microsystems, Inc.
Jan 10, 2014 T:slim Insulin Delivery System Insulin Infusion Pump Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for... Class I Tandem Diabetes Care Inc
Jan 10, 2014 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral St... This single manufacturing lot has the potential for the bond strength between the Trabecular Meta... Class II Zimmer, Inc.
Jan 10, 2014 Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics ... Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Dir... Class II Focus Diagnostics Inc
Jan 9, 2014 Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS So... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s:... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 VITROS Chemistry Products White Reference Slides, White Correction Factor Sli... An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (fi... Class II Ortho-Clinical Diagnostics
Jan 9, 2014 Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dress... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with th... Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Jan 9, 2014 Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 668... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being used. Class II Mako Surgical Corporation
Jan 8, 2014 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No.... OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical ... Class II OrthoPediatrics Corp
Jan 8, 2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or ... The incorrect voltage component was placed into the device during manufacturing. This may make th... Class II Cincinnati Sub-Zero Products Inc
Jan 8, 2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with L... Anspach product code L-3SD contained product code S-3SD which is shorter in length than the label... Class II The Anspach Effort, Inc.
Jan 8, 2014 IMPAX RIS QDOC 5.8 Patient name displayed (printed) on the Patient Report was the wrong patient name. Class II AGFA Corp.
Jan 8, 2014 SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sit... Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Set... Class II B. Braun Medical, Inc.
Jan 8, 2014 CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRAC... Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Class II Veridex, LLC

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.