Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall Cortical Screw for M/DN Intramedullary Fixation The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Computed Tomography X-ray system A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PRI Femoral Impactor Block for knee prosthesis surgery Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in Coreva Health Science, LLC. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereArizona, Florida, New York, Texas, Virginia and Washington
- Medical device recall Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters The product failed to meet the internal established statistical test requirement for heparin activity. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tibial Alignment Guide Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Indiana, Michigan, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall The Alcon Custom Pak The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dade Actin Activated Cephaloplastin Reagent Recovery for assayed controls are out of assigned ranges. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 10, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall syngo Workflow SLR A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.via and Syngo.x measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products Signal Reagent The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels. Class IIIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Systems LOCI Thyroid Stimulating Hormone Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL Incorrect expiration date on label Class IIFDA’s classJun 10, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Illinois, Ohio, Pennsylvania and Tennessee
- Medical device recall EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest Multi-stage treatment option for the EC-5000 Operator’s Manual was not approved by the FDA. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC… affected parts and lots of the Cannulated Drill Bits have the potential to break during use Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in… Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement Report41 statesnamed in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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