Halyard 50482Recalls & reported problems
O&M Halyard, Inc. · HALYARD* PURPLE NITRILE-XTRA* Powder-Free Exam Gloves, S · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651504825), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024Defective Device; Non Reproducible Results; Defective Device; Non Reproducible Results
HOLES WERE REPORTED TO BE FOUND ON THE GLOVES AND AN EMPLOYEE CAME IN CONTACT WITH HEPATITIS B. THE CUSTOMER STATED THERE WAS NO MEDICAL INTERVENTION AND THERE WERE NO INJURIES REPORTED. EMPLOYEE WAS TESTED FOR HEPATITIS B UPON AWARENESS OF ISSUE. ADDITIONAL INFORMATION WAS REQUESTED ON OCTOBER 31, 2024, AND IT WAS REPORTED THE EMPLOYEE IS CURRENTLY FINE AND WILL HAVE A FOLLOW UP BLOOD TEST ON (B)(6) 2024 FOR HEPATITIS B.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679807 ↗
Other Patient examination glove, specialty devices
- PremierPro D5061Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5064Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5063Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5062Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5065Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- Halyard 55090O&M Halyard, Inc. · Patient examination glove, specialty2 reports
- Halyard 47375O&M Halyard, Inc. · Patient examination glove, specialty2 reports
- PremierPro 5063Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page