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 HemosIL LMW Heparin Controls Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zvu Anorectal Manometry Procedure Kit Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration… Class IIIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 20, 2025ClassClass IIIStatusOngoingWhereNationwide, and Colorado, Massachusetts, New Mexico and Ohio named
- Medical device recall Plum Duo Infusion System, List Number: 400020401 ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Microbore Extension Set with 0.2 Micron Filter Label is incorrect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement Report32 statesnamed in where it went PublishedAug 13, 2025ClassClass IStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wyoming
- Medical device recall BD Alaris Pump Module Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Alaris Pump Infusion Sets Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac… Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall BritePro Solo Mini with Pro Miller Blade Size 1.5 Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U Laryngoscope handles may not illuminate as intended. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 13, 2025ClassClass IStatusOngoingWhereNationwide, and Georgia, Michigan, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming named
- Medical device recall BD Trucount Controls, 30 Test Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, New York and Tennessee named
- Medical device recall BD Trucount Controls, 30 Test Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, New York and Tennessee named
- Medical device recall Pinnacle 3 with TumorLOC Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the “Stopping Power Ratio” (SPR) , Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide, and West Virginia named
- Medical device recall LAPAROSCOPIC TRAY CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall CARDIAC ROBOT PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall CT DAVINCI. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall DA VINCI PACK URO/PROSTATE CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall DAVINCI TRUCUSTOM BUNDLE CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall DAVINCI UROLOGY CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GEN LAPAROSCOPY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GENERAL LAPAROSCOPY TRAY CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GENERAL ROBOTIC PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GS ENDOSCOPY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GYN LAPAROSCOPY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall GYN ROBOTIC PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall HVI CARDIAC ROBOT PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall LAP CHOLE PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall LAPAROSCOPIC GYN CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall LAPAROSCOPIC PROSTATECTOMY CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall LAPAROSCOPY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall LAVH PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall MAJOR THORACOSCOPY BASIN CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall PACK GENERAL ROBOTIC CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall PARTIAL NEPHRECTOMY - ROBOTIC CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall PARTIAL NEPHRECTOMY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall ROBOTIC PROSTATECTOMY PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall ROBOTIC URO/GYN PACK CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington
- Medical device recall UIBC (Unsaturated Iron Binding Capacity) Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Colorado, Connecticut, District of Columbia, Delaware, Idaho and Utah
- Medical device recall Brand Name: T4 Total ELISA Product Name: T4 Total ELISA An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and… Class IIIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 13, 2025ClassClass IIIStatusOngoingWhereNationwide, and California, Massachusetts and Pennsylvania named
- Medical device recall UniCel DxI 800 Access Immunoassay Analyzer Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 800 Access Immunoassay Analyzer W/Dual Gantry Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 800 Access Immunoassay Analyzer W/Spot B Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UniCel DxI 600 Access Immunoassay Analyzer Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 600 Access Immunoassay Analyzer W/Dual Gantry Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 600 Access Immunoassay Analyzer W/Spot B Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc BGEM BUN Test Card [25pk] Siemens Healthcare Diagnostics Inc. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 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.”
Your shortlist0 of 4
Add one more to compare.