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 5, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24” X 4” 2-Line, Yellow Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30” X 4” 1-Line, White Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30” X 4” 2-Line, White Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34” X 4” 1-Line, Blue Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34” X 4” 2-Line, Blue Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44” X 4” 1-Line, Green Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44” X 4” 2-Line, Green Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20” DUAL BLADDER, 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20” DUAL BLADDER, 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26” DUAL BLADDER, 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15” 1 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18” 2 LINE Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: Ferndale Laboratories Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall NovaSeq 6000Dx including DRAGEN Server Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Massachusetts, Maryland, North Carolina, New Jersey, Texas and Utah named
- Medical device recall Philips Medical Systems Technologies Ltd The Bolus tracking scan application may crash with a system error message. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/… Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2026ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2026ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall VentStar Resus Neo Potential cracks in the hose, which could lead to leakage or the hose falling off. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 7, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 HeartSine samaritan PAD (Public Access Defibrillator) Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. Class IIIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 7, 2026ClassClass IIIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall McKesson CONSULT hCG Urine Cassette hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Fisher Scientific Sure-Vue Serum/Urine hCG hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Fisher Scientific Sure-Vue Urine hCG Strip hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Fisher Scientific Sure-Vue Urine hCG hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model… Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2)… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Philips IntraSight Plus Software system may associate image data from one patient with another patient’s record, potentially resulting in incorrect diagnosis or treatment. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia, Massachusetts, Minnesota and Texas named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Computed Tomography X-ray System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
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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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