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 CareFusion AVEA ventilator, all models A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 3, 2015ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Georgia, Guam and Puerto Rico named
- Medical device recall SOMATOM Emotion 6 Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body… Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SOMATOM Perspective Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MX8000 Dualv The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT Big Bore Oncology The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 64 The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 40 The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 16 Power The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 16 Water The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 16 Air The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 10 Air The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT 6 Air The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance iCT The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity CT The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Water bottles The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Liquid Waste Bottle The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accessory Kit The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Direct Water feed Kit The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Water Feed Kit The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Liquid Waste Bottle Kit The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Elastic Ankle Support The product does not bear the caution label regarding latex content. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportHawaiithe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereHawaii
- Medical device recall Elastic Knee Support The product does not bear the caution label regarding latex content. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportHawaiithe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereHawaii
- Medical device recall Keo Brace, elastic wrist brace for carpal tunnel The product does not bear the caution label regarding latex content. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportHawaiithe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereHawaii
- Medical device recall SIEMENS Ysio Max Study and all acquired images deleted when using systems with software version VE10E. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies Study and all acquired images deleted when using systems with software version VE10E. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Luminos Agile Max Study and all acquired images deleted when using systems with software version VE10E. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Uroskop Omnia Max Study and all acquired images deleted when using systems with software version VE10E. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EliteCore Full Core Biopsy Device Potential for the device cannula to overthrow past the intended length. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall LCS COMPLETE RPS Femoral Implants, various sizes and orientation The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LCS COMPLETE RPS inserts, various sizes The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EXPEDIUM Spine System/Synapse System Device does not mate as intended. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall D2-40 (Lymphatic Marker) Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. Class IIIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 3, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Michigan, Missouri, North Carolina, South Carolina and Wisconsin named
- Medical device recall Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i… High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105) The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, Michigan, North Carolina, Texas, Virginia and Washington named
- Medical device recall RaySearch RayStation 2.5, 3.0, 3.5 and 4.0 RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40 Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical… It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNew York, Ohio and Texas
- Medical device recall Catalys Precision Laser System-Catalys - U - US product Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CODMAN 3000 Series Refill Set- Huber needles Needle is leaking from hub/needle cannula connection Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volk 25D Large Clear BIO Lens with case Mislabeling. Class IIIFDA’s classJun 3, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 3, 2015ClassClass IIIStatusTerminatedWhereMassachusetts and Virginia
- Medical device recall MEDRAD¿ Stellant CT Injector System with Certegra Workstation The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated… Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated… Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane… A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The… A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass 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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