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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Volk Single Use Vitrectomy Lenses 1 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical 1. 23GA Laser Probe Curved There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G… There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive… There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 25GA Subretinal Injection Cannula VS0220.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX… There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical 25GA I.D.D There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Tecfen Retractable Membrane Polisher, QTPR1267-23 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical I2 Injection Kit, VS0500 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical TID Pharos Illuminated Depressor, VS0801B XXX Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical 25GA Backflush, VS0270.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LotFancy Urinary Tract Infection Urine (UTI) Test Strips Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall The Girlfriend Doctor Dr Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall LH One Step Ovulation Test Device (Urine) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Menopause Test Cassette (Urine) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall S. Typhi/Para Typhi A Antigen Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Male Fertility Sperm Test for Home Use (Cassette) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Exploro Highly Sensitive Male Fertility / Sperm Concentration Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Vivoo pH Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Vivoo Protein Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Vivoo Vaginal pH Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Vivoo Sodium Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named
- Medical device recall Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming 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.”
Your shortlist0 of 4
Add one more to compare.