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 Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall CardinalHealth Suction Canister Liner, MEDI-VAC CRD The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings,… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings,… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings,… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Maquet PowerLEDII OR Light System A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Rolite OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Equipment OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Orchide OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet PowerLED/HLED and PowerLED300 OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Axcel / Axcel + OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Hanaulux HLX3000 OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet XTen OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Prismalix OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Hanaulux HLX2000 OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet G8 / G8E OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Blueline Series 30/80 OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems A potential for a light system to fall in the operating room. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont and Wisconsin named
- Medical device recall CD11b APC: ASR In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter… Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oscor Introducer Kit, 14Fr x Short Individual Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Oscor Introducer Kit, 14Fr x Long Individual Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Flo-Rester, Disposable internal vessel occluder Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Coseal Premix, Surgical Sealant Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Ostene Hemostasis Material Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Vascular Probe Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Preveleak Surgical Sealant Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Floseal Hemostatic Matrix Fast Prep Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter FloSeal Hemostatic Matrix RECOTHROM Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Flo-Thru Intraluminal Shunt Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Peri-Guard Repair Patch Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Peri-Guard Repair Patch Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vascu-Guard Peripheral Vascular Patch (US) Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter FloSeal Hemostatic Matrix NL, 5 mL Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PERI-GUARD SUPPLE Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vascu-Guard Peripheral Vascular Patch (GLOBAL) Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
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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