Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall System 1 Base, 220/240V Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 25, 2012ClassClass 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, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall LMA Esophageal Intubation Detector (EID) The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112 EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereKentucky, Ohio and Tennessee
- Medical device recall OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate… Please be aware that this is not a new recall. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide… Please be aware that this is not a new recall. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic,… Please be aware that this is not a new recall. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Illinois, Massachusetts, Minnesota, New Jersey, Oklahoma, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm’s 510k due to light transmitting fiber material difference. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a… Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine… Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gram Crystal Violet 250 mL Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker AVS Navigator Trials 6mm-15mm Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc… Customer reported problem while performing incoming QC of newly received lot of test cards. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall Hudson RCI Concha Therm Neptune Humidifier Speaker Failure. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes… Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Maryland, Michigan, North Dakota, New York, Ohio and Texas named
- Medical device recall Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence… A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Varian brand Varian Eclipse Treatment Planning System for radiotherapy Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 4 pump 115V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 5 pump 115V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 4 pump 220/240V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 5 pump 220/240V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 4 pump 100V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 8000 base, 5 pump 100V Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 9000, 115V with color screen Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 9000, 220/240V with color screen Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Modular Perfusion System 9000, 100V with color screen Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the… A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB,… Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB),… Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin,… Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of… Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having… Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereConnecticut, Georgia, New Jersey, New York and Virginia
- Medical device recall Dual Incu i, (Atom Infant Incubator There is a potential for the device’s canopy to move unintentionally when using the incubator mode or radiant warmer mode. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 18, 2012ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Safedraw Venous Close Loop System, Blood Sampling Set Some of the kits may exhibit a potential defect with the pouch seal. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Encore Mobile Patient Lifter ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Chorus Mobile Patient Lifter ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sara Plus Mobile Patient Lifter ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drager PT 4000 Phototherapy System A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New York, Ohio and Texas
- Medical device recall CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR,… The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Massachusetts, New Jersey, Washington and Wisconsin
- Medical device recall CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D… The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Massachusetts, New Jersey, Washington and Wisconsin
- Medical device recall CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D… The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Massachusetts, New Jersey, Washington and Wisconsin
- Medical device recall CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D… The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Massachusetts, New Jersey, Washington and Wisconsin
- Medical device recall CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR,… The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Massachusetts, New Jersey, Washington and Wisconsin
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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