Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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 7, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Ingenia 1.5T S There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panorama 1.0T There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia 3.0T There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia 1.5T There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia Ambition S There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia Ambition X There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia Elition S There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia Elition X There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Achieva 3.0T for PET There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Achieva 3.0T TX for PET There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NZM101 Ingenia 1.5T Linac There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multiva 1.5T 8 R5 There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multiva 1.5T There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Phoenix AST-s Indicator Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Phoenix AST Indicator Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Phoenix AP AST Indicator Bag Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Sensis Vibe System A software error may result in a system crash. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall Vanguard Knee System Series-A Standard Patella sizes 31mm Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereMinnesota and Virginia
- Medical device recall Vanguard Knee System Series-A Standard Patella sizes 34mm Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereMinnesota and Virginia
- Medical device recall The WinStation Retinal Imager, also known as Merge Eye Station Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall AF w/AS 550 x 1-14ML/HR CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF550x5ML/H 2ML 60LO 6” CATH, 4.5” IN Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF550x5ML/H 2ML 60LO 6” DUAL CATHS, 4.5”, Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0F 550 x 8ML/HR 2ML 60LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 5ML/H 6” CATH, 4.5” IN Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 5ML/H 6” DUAL CATHS, 4.5” Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 5ML/H FH DL 30hole SAT C,4”IN Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 5ML/HR 2ML 60LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 5ML/HR CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF 550x8ML/H 2ML 15LO 8.7” DUAL CATHS, 4 Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB Possible cracks on the body of the fill port connector, which may result in a leak. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity All Purpose Sponges, Non-woven, 4 Ply, 4” x 4” Curity All Purpose Sponges were not sterilized and distributed Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in… Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Iowa, Louisiana, Maryland, Ohio and South Carolina named
- Medical device recall BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic… Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana, Ohio and South Carolina named
- Medical device recall PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in… Incorrect expiration being entered for one lot. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and North Carolina and New York named
- Medical device recall Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during… Potential for the optical head to detach from the stand due to the lack of thread adhesive. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Vitek 2 reagent cards: a) GN ID This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in… Incorrect (higher) Rated Burst Pressure information printed on label. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportMissourithe one state its words name PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereMissouri
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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