Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Model Number SM-32HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model SM-32HF-Batt Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-Batt Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Sedecal Easy Moving Plus Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-40HF-B-D-C Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall RADPRO MOBILE, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SED URS LP, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SHIMADZU RF.004, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SM_40HF_B_D_VIR3, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SM_40HF_B_D_VIR3.004, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SM_40HF_BDC, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall SM_40HF_BDC3, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall HeartSine Pad-Pak Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artegraft¿ Collagen Vascular Graft The device was incorrectly packed in the wrong size labeled outer packaging. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportArkansasthe one state its words name PublishedOct 29, 2025ClassClass IIStatusOngoingWhereArkansas
- Medical device recall Elscint Cardial GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Elscint SPX4 GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Elscint SPX6 GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Elscint Varicam GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Elscint Helix GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Millenium MG/MC GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Millenium Myosight GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Millenium MPR GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Millenium MPS GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state 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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