Halyard 76727Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651767275), 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).

1 other recall cover devices cleared under the same FDA submission (K974068); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

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 17346421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974068. One submission often covers many models, so check the product and lot details in each record.

• Z-2626-2023 · Aug 9, 2023 · Open, Classified
  FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827