Medical devices, 2024
Shortlist up to four to read them side by side.
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 VITROS 5600 Integrated System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS XT 3400 Chemistry System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS XT 7600 Integrated System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS 3600 Immunodiagnostic System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS 4600 Chemistry System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS 5600 Integrated System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 3400 Chemistry System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 7600 Integrated System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal… Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive… Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal… Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal… Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Products not sterilized, sterility cannot be confirmed Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DISP.TROCAR W The sterile blister packaging may be damaged, and sterility may be compromised. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Kansas, New Jersey and New York named
- Medical device recall DISP.HASSON TROCAR 10/110MM The sterile blister packaging may be damaged, and sterility may be compromised. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Kansas, New Jersey and New York named
- Medical device recall DISP.TROCAR W.DILATING PIN 12/110MM The sterile blister packaging may be damaged, and sterility may be compromised. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Kansas, New Jersey and New York named
- Medical device recall DISP.TROCAR W.DILATING PIN 12/110MM The sterile blister packaging may be damaged, and sterility may be compromised. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Kansas, New Jersey and New York named
- Medical device recall DISP.HASSON TROCAR 12/110MM The sterile blister packaging may be damaged, and sterility may be compromised. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Kansas, New Jersey and New York named
- Medical device recall MRI system: Vantage Orian, Vantage Fortian For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in “System Information” of the operation window… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MRI system: Vantage Elan For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in “System Information” of the operation window… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Vantage Titan For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in “System Information” of the operation window… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed… European version of microcatheter were distributed within US which contain a different “Indications for Use”. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed… European version of microcatheter were distributed within US which contain a different “Indications for Use”. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Phantom TTC Nail, 10.0 X 200mm, Right Medical devices distributed, prior to sterilization Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 13, 2024ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT Medical devices distributed, prior to sterilization Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 13, 2024ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT Medical devices distributed, prior to sterilization Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 13, 2024ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Embrace Drill Tower, Wedged The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions (“standard” vs… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama and Louisiana named
- Medical device recall Embrace Drill Tower, Standard/Lateral The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions (“standard” vs… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama and Louisiana named
- Medical device recall X3 TRIATHLON CS INSERT NO 3 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall X3 TRIATHLON CS INSERT NO 6 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall X3 TRIATHLON CS INSERT NO 6 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall X3 TRIATHLON CS INSERT NO 7 9 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Synapse PACS - Version 7.1.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Synapse PACS - Version 7.1.000US Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Synapse PACS - Version 7.2.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Synapse PACS - Version 7.2.100 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Synapse PACS - Version 7.2.200 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Synapse PACS - Version 7.3.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. Class IIFDA’s classMar 13, 2024in FDA’s Enforcement Report12 statesnamed in where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereAlaska, California, Florida, Illinois, Indiana, Michigan, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Texas
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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