Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Individual units labeled in part Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, New York, Oregon, Puerto Rico, Texas and Virginia named
- Medical device recall da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000 Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an… Class IIIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are… Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Fresenius Liberty¿ Cycler Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Adjustable Gastric Band During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Adjustable Gastric Band During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Adjustable Gastric Band During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated… The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference)… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry… The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference)… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient… An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column. Class IIIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 13, 2013ClassClass IIIStatusTerminatedWhereNew Jersey
- Medical device recall Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Spinal Tray with Drugs 22g/25g Quincke Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Spinal Tray with Drugs 25g Whitacre Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Regional Anesthesia Tray with Drugs Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Spinal Tray with Drugs 25g Whitacre Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Spinal Tray with Drugs 25g Whitacre Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is… Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer) Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Portex¿ Saddleblock Tray with Drugs 25g Quincke Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall OmniPod Insulin Management System Starter Kit Alcohol Prep Pads contained within the kit are not properly labeled. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OmniPod Insulin Management Product Demonstration Kit Alcohol Prep Pads contained within the kit are not properly labeled. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting… The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedNov 13, 2013ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VitreaCore¿ software Vital Images, Inc. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall HAMILTON-C2 Ventilator Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall Handset component of the Handicare USA’s Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss) Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Intact PTH Calibrator PTH Calibrator packaged with only high calibrator. Class IIIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 13, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Connecticut, Maryland and Pennsylvania named
- Medical device recall US Safire Duo Ablation Catheter MediGuide Enabled St. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereKansas, Kentucky, Massachusetts, Ohio, Texas and Utah
- Medical device recall pH 7.0 Buffer Solution Pint and Quart Bottles Mesa Laboratories, Inc. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pinook Mini Massager Failure to submit a premarket submission and gain approval of a medical device. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Guam, Illinois, Massachusetts, Maryland, Missouri, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall Pinook Micro Massager Failure to submit a premarket submission and gain approval of a medical device. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Guam, Illinois, Massachusetts, Maryland, Missouri, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereKentucky and Utah
- Medical device recall DRX- Revolution Carestream Health Inc. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall CARESTREAM DRX -Mobile Retrofit Kit Carestream Health Inc. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Imprecision with certain lots Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran Mini CT Scanner A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran MiniCAT CT Scanner A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran Minicat00202 The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 ¿ 3 kVp. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran Minicat00158 The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 ¿ 3 kVp. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran MiniCAT00202 The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 ¿ 3 kVp. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xoran MiniCAT CT Scanner ID ENT00001 Failure of the gantry to rotate. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits,… Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due to concerns raised by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 6, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron… Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named
- Medical device recall Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul¿ Head The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass 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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