Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0,… A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0,… A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0,… A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall Alcon PRECISION1 One-Day Contact Lenses, -2.25D. Potential for a weak seal in some units resulting in compromise in sterility. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Connecticut, Florida, Iowa, Idaho, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas and Washington
- Medical device recall VANTAGE GALAN 3T Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNevada and Ohio
- Medical device recall ChemoLock Bag Spike, 01 units Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Chemo Lock Universal Vented Vial Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock” Port, Bulk, Non-Sterile Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Clave Bag Spike w/ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 30” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 30” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Oncology Kit w/31” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Bag Spike with Clave Additive Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 45” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 60” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 73” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Bag Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Double ChemoLock Port Syringe Transfer Set Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Universal Vented Vial Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Vented Vial Spike, 20mm Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Vented Vial Spike, 13mm Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Closed Vial Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Vial Spike, 20mm Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock 13mm Closed Vial Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 21” Ext Set w/ChemoLock Port, Clamp, Graduated Connector Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Graduated Connector w/ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 6.5” Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock w/Mini Bag Spike ¿ Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemoLock Port w/Spiros, Red Cap Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 8” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 31” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 7.5” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical 6” Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical Oncology Kit w/2 ChemoLock”, 13mm Closed Vial Spike w/ChemoLock” Port, ChemoLock” Bag Spike, Ext… Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemosafeLock Bag Spike Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemosafeLock Connecter Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 Port weld of drug transfer device may separate or break during use and potentially result in a leak. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall Assay: IMMULITE 2000 Intact PTH The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Idaho, Indiana, Louisiana, Maryland, North Carolina, New Jersey, New York, Pennsylvania and South Carolina named
- Medical device recall Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01… Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01… Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass 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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