Halyard 53140Recalls & reported problems
O&M Halyard, Inc. · HALYARD* STERLING* NITRILE-XTRA* Powder-Free Exam Gloves, L · Class 1
- 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 20680651531401), received between Dec 11, 2023 and Dec 11, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Incompatible1
Patient problems
- Local Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2023Component Incompatible; Component Incompatible
AN EMPLOYEE REPORTED THAT WHILE WEARING GLOVES THEY SMELLED A CHEMICAL AND STARTED COUGHING IMMEDIATELY. THE EMPLOYEE HAD DIFFICULTY BREATHING. THERE WERE ODORS ALSO REPORTED FROM GARBAGE WHERE GLOVES WERE DISPOSED OF PREVIOUSLY. THESE ODORS TRIGGERED MORE COUGHING AND DIFFICULTY BREATHING FROM THE EMPLOYEE. THE REPORTER INDICATED THERE WAS MEDICAL INTERVENTION TAKEN, BUT THEY WERE UNWILLING OR UNABLE TO PROVIDE FURTHER DETAILS WITH US WHEN ASKED.
Patient problems: Local Reaction
MAUDE report 18307319 ↗
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 D5062Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5065Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty1 recall0 reports
- PremierPro D5063Prestige 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
- FLEXAL 88FS03MCardinal Health 200, LLC · Patient examination glove, specialty1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.