Halyard 32856Recalls & reported problems
O&M Halyard, Inc. · HYH,PROC,MASK,-,CHILD,75 · Class 2
- 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 20680651328568), received between Jul 18, 2023 and Jul 18, 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.
Most reported problems
Device problems
- Component Incompatible1
Patient problems
- Angioedema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2023Component Incompatible; Component Incompatible
CUSTOMER LAST WORKED (B)(6) 2023 AND GOT ON DISABILITY BECAUSE SHE IS UNABLE TO WEAR MASKS PROVIDED AT HER PLACE OF WORK. CUSTOMER STATES THERE WAS REDNESS AND IRRITATION TO FACE, UNDER EYE TO NECK. A PATCH TEST WAS PERFORMED. CUSTOMER WAS PRESCRIBED ANTIHISTAMINES, PREDNISONE, AND AN EPIPEN FOR USE IN AN ALLERGIC EMERGENCY.
Patient problems: Angioedema
MAUDE report 17345228 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.