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 Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile) The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Prodiva CS, Model Number 781069. 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 Prodiva CX, Model Number 781070. 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 (ZBO) 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 16 R5 (ZBO) 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 16 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 Intera 0.5T Standard 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 Intera 1.0T Omni/Stellar 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 Intera 1.0T Power/Pulsar 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 Intera 1.5T Omni/Stellar 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 Intera 1.5T Power/Pulsar 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 Intera 1.5T Master/Nova 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 Intera 1.5T CV 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 Intera 1.5T Explorer/Nova Dual 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 Enterprise 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 Intera 3.0T Master/Quasar Dual 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 XR 1.5T/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 Intera IT, Model Number 781160. 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 Intera 1.5T R11 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 Intera Achieva 1.5T Pulsar 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 Intera Achieva 1.5T Nova 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 Intera Achieva 1.5T Nova Dual 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 Intera 1.5T Achieva CV Nova 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 Intera Achieva 1.5T IT Nova 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 Intera Achieva 1.5T IT Nova Dual 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 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 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 Intera 1.5T, Model Number 781195. 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 1.5T High Performance 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 7.0T 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 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 Achieva XR 1.5T/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 SmartPath to dStream for 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 1.5T CX 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 CX (ZBO) 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 SmartPath to dStream for XR and 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 3.0T CX 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 X-series 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-series 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 1.5T Conversion 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 Intera 1.5T High Performance 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 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 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 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 Achieva 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 Achieva 3.0T 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 Achieva 3.0T TX 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 1.5T Conversion 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
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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