Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Composix” LP with Echo PS” 6 x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Composix” LIP Mesh with Echo PS” 7”x9” Reorder Number: 0144790 Indicated for use in the reconstruction… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Composix” LIP Mesh with Echo PS” 8”x10” Reorder Number: 0144810 Indicated for use in the reconstruction… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿Ventralight” ST Mesh with Echo PS” 10”x13” Reorder Number: 5955113 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 12”x14” Reorder Number: 5955124 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 4.5” Circle Reorder Number: 5955450 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 4”x6” Reorder Number: 5955460 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 6” CircleReorder Number: 5955600 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 6”x10” Reorder Number: 5955610 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 6”x8” Reorder Number: 5955680 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS TM 7”x9” Reorder Number: 5955790 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 8” Circle Number: 5955800 Indicated for use in the reconstruction of… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard¿ Ventralight” ST Mesh with Echo PS” 8”x10” Reorder Number: 5955810 Indicated for use in the… Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm… New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereArkansas, California, North Carolina and Texas
- Medical device recall Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue… Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida and New York named
- Medical device recall Cochlear Baha Soft tissue gauge 6mm Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039 Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereCalifornia, New York, Puerto Rico and Texas
- Medical device recall Hologic M-IV Mammography System Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereCalifornia, New York, Puerto Rico and Texas
- Medical device recall LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids… There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Puerto Rico and US Virgin Islands named
- Medical device recall Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps,… There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Puerto Rico and US Virgin Islands named
- Medical device recall Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL… There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Puerto Rico and US Virgin Islands named
- Medical device recall Spacelabs Medical Ultraview SL Command Module A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray… GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Kentucky, Massachusetts, Nebraska, New York, Tennessee and Texas named
- Medical device recall Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software Potential for patient to be marked incorrectly. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report36 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wyoming
- Medical device recall Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM… Product does not function as intended up to the expiry date on the product labeling. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Missouri, Mississippi, North Carolina, New York and Pennsylvania named
- Medical device recall AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system… It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD)… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall PATH(R) THREAD CUP ADAPTOR Difficulty removing the cup adaptor from the impaction handle during surgery Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or… Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Toshiba Infinix X-Ray Interventional System INFX-8000V/UU Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and California and Indiana named
- Medical device recall The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite… The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Montana, Nevada and Texas
- Medical device recall The NAV3i Platform Power Box supplies the electrical components with power (e.g The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Montana, Nevada and Texas
- Medical device recall Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in… Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc Torque wrenches used to tighten certain PSC bolts were out of calibration. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall MACROLYTE Premie Dispersive Electrode ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures… Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Indiana, North Carolina, New Hampshire and Washington named
- Medical device recall Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To… The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator… Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Illinois, Kansas, North Carolina, Nebraska, New York, Ohio, Oklahoma, Puerto Rico and Texas named
- Medical device recall Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT,… A customer reported that the table top had become free floating. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia and Puerto Rico named
- Medical device recall Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal… Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportConnecticutthe one state its words name PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereConnecticut
- Medical device recall Siemens Linear Accelerator (LINAC) models Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Illinois, Maine and Pennsylvania named
- Medical device recall ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems TSH3 Ultra 2500 tests Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems VitD 100 test, Ready Pack Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems VitD 500 test, Ready Pack Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Systems BRAHMS PCT 100 test Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
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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