Halyard 47636Recalls & reported problems
O&M Halyard, Inc. · AQUASOFT* Powder-Free Nitrile Exam Gloves, M · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651476368), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Component Incompatible” (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
- Component Incompatible1
Patient problems
- Anaphylactoid / Anaphylaxis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2024Component Incompatible; Component Incompatible
THERE WAS ONE EMPLOYEE THAT SHOWED SIGNS OF CONTACT DERMATITIS AFTER USING THE BLUE NITRILE GLOVES. SHE DEVELOPED SWOLLEN LIPS, TINGLING AND HAD COMPLAINTS OF SHORTNESS OF BREATH AND THROAT TIGHTENING THAT WAS AUDIBLE.
Patient problems: Anaphylactoid / Anaphylaxis
MAUDE report 21023764 ↗
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.
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