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Recalls Medical devices 2013

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

By the year FDA published them20262,589 20252,908 20243,394 20232,477 20222,192 20212,303 20203,055 20192,801 20183,757 20172,615 20163,246 20152,495 20143,05920132,24920121,310

Filters

FDA’s class Class IClass IIClass III

FDA’s own classes: Class I is the most serious. Each recall’s page quotes FDA’s definition.

Status, in FDA’s file OngoingTerminated

Where it went, in FDA’s words FDA says nationwideAlabamaAlaskaAmerican SamoaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaGuamHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaPuerto RicoRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUS Virgin IslandsUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyoming

The states FDA’s words on where the product went name. “Nationwide” is its own choice: to FDA it means the fifty states or a significant portion, so a recall is never counted for a state its words don’t name.

The reason May fail, or give wrong resultsSterility not assuredLabels that are wrong or missingChemicals, metals or drugs that shouldn’t be in itPieces of metal, glass or plasticStrength, purity or how it was madeGerms: Listeria, Salmonella, E. coli and others

Grouped from FDA’s own reason for each recall, which every record shows in full.

Published in FDA’s report

Any

In FDA’s record Class IStill ongoing

The list

Filter by product, brand, reason or number

Order the list NewestNewest firstNameName

Medical device recallsPublishedClassStatusWhere

Medical device recall Plum A+ Infusion Pump Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Plum A+ Infusion Pump Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall *** 1) Plum A+ Infusion Pump Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Composite Series Skull Clamp, one clamp per tote An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Mississippi, New York, Ohio, South Carolina, Tennessee and Texas
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin
Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin

Before these 289 to 336 of 2,249 After these

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.”

Medical devices, 2013

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State average 14.3

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