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 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 3.0T The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blood Pump Rotor An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2008T BlueStar Hemodialysis Machine An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2008T BlueStar Hemodialysis Machine An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2008T BlueStar Hemodialysis Machine An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2008T BlueStar Hemodialysis Machine An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prelude Guide Sheath Roadster Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Prelude Guide Sheath Roadster Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall SURGIFOAM” Absorbable Gelatin Powder Kit Some applicator tips from these lots had open seals. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall Cascade IOMAX Cortical Module There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall Stryker Blueprint Software The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, New Jersey and Wisconsin named
- Medical device recall Noblus AC Adapter used with the Noblus Ultrasound Imaging System AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16 Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Anti-TG Ab The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Hawaii, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Washington and Wisconsin named
- Medical device recall IMMULITE 2000 Anti-TG Ab The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Hawaii, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Washington and Wisconsin named
- Medical device recall InstaClear Lens Sheath Potential for distal end of the sheath to break off during a procedure. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 30ML/LS Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 30ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 60ML L/S Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 60ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 10ML L/S Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 10ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 3ML L/S Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 3ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 5ML L/S Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 20ML L/S Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 20ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 1ML TB Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and 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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