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 7, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or… Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only) If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Beckman Coulter, Lipase Assay N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Beckman Coulter, Uric Acid Assay N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Beckman Coulter, Cholesterol Assay N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Beckman Coulter, Lactate Assay N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process,… In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes The outer box label is marked with the correct expiration date of 08/2016. Class IIIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedFeb 4, 2015ClassClass IIIStatusTerminatedWhereFlorida
- Medical device recall Verasense Knee System Presence of one inoperable (dead) sensor pad. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Michigan, Nevada, New York and Virginia
- Medical device recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with… Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. Class IIIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis The keypad buttons on HomeChoice devices may be activated without the operator pressing them. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report36 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL The lot failed pH specification. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TEGRIS System The wrong movement results on the MAGNUS OR table. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Nebraska, New York and Pennsylvania named
- Medical device recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereIdaho, Illinois, Michigan, Minnesota, Missouri, North Dakota and Pennsylvania
- Medical device recall Ferno Model 35X PROFlexx Stretchers, one unit per package The wheel castor assemblies may be loosening on the stretchers. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereGeorgia, Hawaii, Massachusetts, Missouri, New Jersey, Ohio, Tennessee and Texas
- Medical device recall Powered stretcher chair used during facial and eye surgeries The firm is finding that the stretcher chair controllers are moving the chairs involuntarily. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips IntelliVue TcG10 Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that… Class IIFDA’s classJan 28, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Illinois, Massachusetts, Michigan, Missouri, Montana, North Carolina, Ohio and Pennsylvania
- Medical device recall Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral,… One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. Class IIIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall CD8 (Leu-2a) PE (In vitro diagnostic) One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PF4 Concentrated Wash Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Anti-Lambda APC-H7 Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Michigan and New York named
- Medical device recall Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG) Reports of customers falling from the Inversion Table and sustaining injuries. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS… Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. Class IIIFDA’s classJan 28, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 28, 2015ClassClass IIIStatusTerminatedWhereColorado, Michigan, North Carolina, New Jersey, New York, Pennsylvania and West Virginia
- Medical device recall Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 the Instructions for Use (IFU) were inadvertently removed from the kit. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportKentuckythe one state its words name PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall FLUTTER Percussor respiratory device Customer notification that the device may be difficult to open or close. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, South Carolina and Virginia named
- Medical device recall The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis… The tunneling sheath packaged within the kits can crack during placement. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal… mA Accuracy may exceed the design and labeling specification of+ 10%. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal… mA Accuracy may exceed the design and labeling specification of+ 10%. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Artis zee/ zeego systems The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Hawaii, Indiana, Louisiana, Maryland, Maine, Michigan, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia and Washington
- Medical device recall Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System Lotus valve became unlocked during release from the delivery system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System Lotus valve became unlocked during release from the delivery system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System Lotus valve became unlocked during release from the delivery system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software… During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The x-drive assembly may fail prematurely. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon and Texas
- Medical device recall Merlin@home RF Remote Monitoring Transmitter Transmitter may initiate a software reset resulting in backup operation in some implanted St. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1)… A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida and Texas
- Medical device recall Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003… A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida and Texas
- Medical device recall POWEREASE Instruments Set Screw Breakoff Instrument The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Iowa, Kansas, Kentucky, Michigan, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas and Washington
- Medical device recall The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Proteus XR/a with wall stand GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic,… iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal,… iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Philips Expression MR200 MRI Patient Monitoring System. The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Kentucky, Minnesota, North Carolina, New Jersey, New York, Oklahoma, South Dakota and Texas
- Medical device recall IC PROFILER-MR Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado and Ohio
- Medical device recall Symbia T and Symbia T2 computer tomography systems There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HeartStart MRx Monitor/Defibrillator Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kansas, Massachusetts, Maine, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia
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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