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 CoCr Head (Not 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 NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L 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 NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L 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 Natural-Knee¿ Flex Femoral Component 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 Zimmer¿ Unicompartmental Knee Femoral Component 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 Gender Solutions” Patello-Femoral Component 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 Natural-Knee¿ II Femoral Component 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 Sidus” Head (Not 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 NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not 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 Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE)… Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MAQUET Getinge Group CARDIOHELP Base Unit It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Kansas, Maryland, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia… Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PENTAX Endoscopic Accessories PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedNov 6, 2013ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming named
- Medical device recall HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid,… HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall chromID Salmonella Agar, Reference No. 43621 Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution… Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement Report32 statesnamed in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Vermont, Washington and Wisconsin
- Medical device recall DRX Revolution Mobile X-Ray System During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Louisiana, Massachusetts, New York, Pennsylvania and Texas named
- Medical device recall Edwards Lifesciences EMBOL-X Glide Protection System Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA)… It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended… Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are… Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are… Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are… Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential… Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral… The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0” The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Hawaii, Minnesota, Oklahoma and Texas
- Medical device recall pocH-100i; sysmex; Automated Hematology Analyzer; 7.3” x 13.8” x 18.1” / 30.8 lbs.; Sysmex Corporation; 1-5-1… The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement Report39 statesnamed in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, American Samoa, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200… RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vented Spike Adapter Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci… A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci… A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral… A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, Pennsylvania and Virginia named
- Medical device recall COULTER LH 750 and LH 780 Analyzers The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary… When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Breeze C Scooter is a motorized electric scooter for elderly people Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic… GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino¿ Intracranial Pressure… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images… Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement Report51 statesnamed in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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