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 Terragene Bionova PCD (PCD222-C) Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia, Indiana, Michigan, Montana, New York, Pennsylvania, Texas and Virginia named
- Medical device recall Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm Centered glenosphere box may contain an eccentric glenosphere. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK… Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36… Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Cortera Spinal Fixation System Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportMichiganthe one state its words name PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereMichigan
- Medical device recall Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Loss of connectivity between the FlexArm and the Table due to a software issue. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Illinois, Mississippi, Nevada and Texas named
- Medical device recall Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Illinois, Mississippi, Nevada and Texas named
- Medical device recall smiths medical Medfusion Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical Medfusion Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Voluson IC9-RS intracavitary probes GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4” Needle Holder MB215R was inadvertently distributed as MB362R. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Idaho, Kentucky, Maryland, Missouri, Montana, Nevada, New York, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8 Needle Holder MB215R was inadvertently distributed as MB362R. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Idaho, Kentucky, Maryland, Missouri, Montana, Nevada, New York, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall TERUMO HydroPearl Compressible Microspheres for Embolisation Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Illinois, Louisiana, North Carolina, Tennessee, Virginia and Wisconsin named
- Medical device recall SCORPIO RECESSED PATELLA- Intended for Knee Replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO RECESSED PATELLA- Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO RECESSED PATELLA- Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO RECESSED PATELLA-Intended for knee repalcment Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT-Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacment Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TS TIB INSERT -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO U-DOME PATELLA -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 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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