Halyard 25867Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651258674), received between Aug 11, 2022 and Feb 29, 2024 — 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 29, 2024Compatibility Problem; Compatibility Problem

  COMPLAINANT STATED THAT SHE HAD A MASK SHAPED RASH ON HER FACE FOR FOUR DAYS AFTER USING THE MASK AND COMPLAINED OF AN ODOR FROM THE BOX THAT HAS SINCE DISSIPATED. THERE WAS "BLACK SPOTS" ON SOME MASKS, BREATHING DIFFICULTIES WITH THE MASK AND A FEELING OF INHALING PARTICULATES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18812854 ↗
• 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 17346609 ↗
• InjuryAug 11, 2022Component Incompatible; Component Incompatible

  PATIENT 1 OF 4. EMPLOYEE EXPERIENCED REACTIONS ON FOUR OCCASIONS ASSOCIATED WITH MASK USE. THE REACTION(S) CONSISTENT OF TONGUE FEELING THICK WITH ITCHY THROAT. INITIAL REACTION OCCURRED ON (B)(6) 2022 AND SUBSEQUENTLY ON (B)(6) 2022, (B)(6) 2022 TO (B)(6) 2022 AND (B)(6) 2022 TO (B)(6) 2022. EMPLOYEE HEALTH PRESCRIBED INTRAMUSCULAR EPINEPHRINE, INTRAVENOUS PREDNISONE, BENADRYL, PEPCID, SOLUMEDROL, AND HYDROXYZINE. THE EMPLOYEE FOLLOWED UP WITH AN ALLERGIST AND HAD TWO PATCH TESTS OF STEROIDS. EMPLOYEE WAS REFERRED TO PULMONOLOGIST AND RHEUMATOLOGIST. SHE CURRENTLY CONTINUES BENADRYL, PEPCID, SOLUMEDROL, HYDROXYZINE, 20 MG PREDNISONE, ALLEGRA (TWICE A DAY), AND ZYRTEC (TWICE A DAY) BY MOUTH.

  Patient problems: Local Reaction

  MAUDE report 15211364 ↗