Medical devices, 2024
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3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Neria Soft Infusion Set Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within… Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall CryoValve SG Cryopreserved Pulmonary Human Heart Valve The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium… Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Conversion, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Initial, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0TX for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva XR, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Enterprise 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution Upgrade 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GYROSCAN T10-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GYROSCAN T5, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GYROSCAN T5-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 0.5T Standard, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.0T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Achieva Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Master/Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T R11, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 3.0T Quasar Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera CV, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Identity Imprint PS Tibial Tray Size 4 Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Kansas and New Hampshire named
- Medical device recall Actim PROM dipstik Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false… Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut named
- Medical device recall Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia, Massachusetts, Puerto Rico and West Virginia named
- Medical device recall Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia, Massachusetts, Puerto Rico and West Virginia 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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