Halyard 48100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651481003), received between Apr 7, 2023 and May 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Component Incompatible” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Component Incompatible; Component Incompatible

  INCIDENT TWO. CUSTOMER ADVISED THEY HAVE HAD TWO REACTIONS. THE MASK WAS WORN FOR TEN MINUTES PRIOR TO FACE FEELING HOT AND ITCHY, THEN RED. THE REACTION CONTINUES TO WORSEN EVEN AFTER THE MASK IS REMOVED. FACE AND EYES SHOW SOME SWELLING. CUSTOMER HAS INDICATED THE INITIAL REACTION OCCURRED IN 2021. THEY SWITCHED TO A HYPOALLERGENIC MASK FOLLOWING REACTION. ONLY RECENTLY SHE WAS OUT OF THIS ALTERNATE MASK AND REVERTED TO THE 48100 AT WHICH TIME SHE HAD THIS RECENT REACTION. PRESCRIBED MEDICATION: STEROID CREAM, STEROID ANTIINFLAMMATION MEDS, MEDICATED EYE DROPS, AND USE OF OVER-THE-COUNTER MEDS LIKE BENADRYL. AFTER A WEEK, THE SYMPTOMS STILL REMAINED. THE MEDICATION HAS CLEARED ABOUT 80% OF THE ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22076914 ↗
• InjuryMay 23, 2025Component Incompatible; Component Incompatible

  INCIDENT ONE. CUSTOMER ADVISED THEY HAVE HAD TWO REACTIONS. THE MASK WAS WORN FOR TEN MINUTES PRIOR TO FACE FEELING HOT AND ITCHY, THEN RED. THE REACTION CONTINUES TO WORSEN EVEN AFTER THE MASK IS REMOVED. FACE AND EYES SHOW SOME SWELLING. CUSTOMER HAS INDICATED THE INITIAL REACTION OCCURRED IN 2021. THEY SWITCHED TO A HYPOALLERGENIC MASK FOLLOWING REACTION. ONLY RECENTLY SHE WAS OUT OF THIS ALTERNATE MASK, AND REVERTED TO THE 48100 AT WHICH TIME SHE HAD THIS RECENT REACTION. PRESCRIBED MEDICATION: STEROID CREAM, STEROID ANTIINFLAMMATION MEDS, MEDICATED EYE DROPS, AND USE OF OVER-THE-COUNTER MEDS LIKE BENADRYL. AFTER A WEEK, THE SYMPTOMS STILL REMAINED. THE MEDICATION HAS CLEARED ABOUT 80% OF THE ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22076892 ↗
• InjuryApr 7, 2023Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT A FEW EMPLOYEES WERE HAVING ALLERGIC REACTIONS THAT CAUSED WOUNDS ON THE FACE WHILE WEARING THE MASK.

  Patient problems: Local Reaction

  MAUDE report 16701812 ↗