Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Prodisc C SK U.S Product labeling mix up. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee and Texas named
- Medical device recall Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Due to a manufacturing issue (i.e. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia, Kansas, Michigan, Ohio, South Carolina, Texas and Washington named
- Medical device recall ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201 Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 ERBEFLO 2, Endoscopy Pump Tubing/Cap Set Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255,… Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BioFire Joint Infection (JI) Panel Contamination to in-vitro diagnostic test may result in false positives. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Maryland, North Carolina, Texas and Utah named
- Medical device recall Mint Lesion; Software Versions: 3.4.0 up to 3.9.5. If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps Field Safety Corrective Action for IFU in DEX Forceps and Scissors. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps Ophthalmic Tissue Forceps (DEX”) are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biofire Spotfire Respiratory/Sore Throat Panel Respiratory/sore throat panel test may result in false negative results and control failures. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, Mississippi, Texas and Virginia named
- Medical device recall One Step 10A in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall One Step UTI in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall One Step pH in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall QUCARE Total Cholesterol in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall Uric Acid in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall One Step K in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall One Step P in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall Medline Convenience Kits: 1) ANCILLARY PACK-LF Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) SCC RF PAIN MGMT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ANGIO PROCEDURE PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ANGIO PROCEDURE PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for complete list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PICC LINE TRAY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYNDA3003 Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for full list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for complete list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for complete list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) LITHOTOMY PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for complete list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) CVC PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PPE KIT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ADMIT KIT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) NEURO SHUNT- CODMAN Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) OB KIT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.