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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure… Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall e.cam Gamma Camera, an emission computed tomography system Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMSCO 400 and AMSCO C Small Steam Sterilizers In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal,… Class IIIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Helioseal F Sealant Refill 1 x 1.25 g A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the… Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Illinois, Indiana, Missouri, New Jersey, Pennsylvania, South Carolina, Texas, Washington and Wisconsin named
- Medical device recall Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose… ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL)… ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder… ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450… ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is… Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4,… MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision… There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Puerto Rico, Rhode Island, South Dakota, Texas, Virginia and West Virginia named
- Medical device recall SmartSite Extension Set CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile The Inserter Inner Shaft would not fit through the Inserter. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLAIR Endovascular Stent Graft Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related… Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector) The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms)… Inaccurate distance measurements with magnified projection X-ray images. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and… Inaccurate distance measurements with magnified projection X-ray images. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Surgical Display User settings were no longer on the monitor’s memory after these systems were powered off and back on. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Jersey, Ohio, Oregon and Texas
- Medical device recall MATResponder Tourniquet Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Regard Custom Surgical Pack The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medical device recall VITROS 5,1 FS Chemistry System Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. Class IIFDA’s classNov 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CIOS ALPHA; image intensified fluoroscopic x-ray system patient procedure interruption due to a potential system failure Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903 May report values outside the published performance specifications for pH. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103 May report values outside the published performance specifications for pH. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood… Some 1 1/4” needles were packaged and labeled in the 1” blister package. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportIndianathe one state its words name PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall Signature Patient-Specific Surgical Guides Potential inaccuracies in the alignment of the guides. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereIdaho, Michigan and Texas
- Medical device recall ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only Incorrect tubing. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Exprt Precision System: Revision Knee The labeling is missing the size/diameter information. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Missouri, New York, Oklahoma, Rhode Island, South Carolina and Wisconsin
- Medical device recall Perkin Elmer Specimen Gate, Screening Center It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereFlorida, Georgia and Nevada
- Medical device recall 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportTennesseethe one state its words name PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS… potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD CD3 (SK7) FITC Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Class IIIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 4, 2015ClassClass IIIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00… When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNebraska, South Carolina and Washington
- Medical device recall Brilliance 16-Slice (Air) Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Brilliance 64 Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Ingenuity Core Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Ingenuity Flex Computed Tomography X-ray systems The firm discovered Ring/Dot artifact due to X-ray measurement error. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Turon Shoulder Impaction Fixture During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reverse Shoulder Prosthesis Stem Impaction Fixture During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for… Unintended update of Dose and MU and Incorrect Assignment of Bolus. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, Missouri, Texas and Wisconsin
- Medical device recall ACUSON SC2000 ultrasound systems Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereGeorgia and Puerto Rico
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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