Halyard 88841Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651888416), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083234); 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.

• MalfunctionSep 13, 2022Component Missing; Component Missing

  REPORTER INDICATES THAT WHILE UTILIZING O&M HALYARD SURGICAL OB PACK, THE QBL (QUANTITATIVE BLOOD LOSS) DRAPE DID NOT CONTAIN THE USUAL MEASURING COMPONENT. THE PATIENT HAD A RETAINED PLACENTA AND POSTPARTUM HEMORRHAGE. REPORTER INDICATES THAT AS A RESULT OF THE MISSING DRAPE MEASURING COMPONENT, THE PATIENT'S BLOOD LOSS WAS LIKELY UNDERESTIMATED UNTIL THEY HAD SYMPTOMATIC ANEMIA. PATIENT DID RECEIVE A BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15414199 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083234. One submission often covers many models, so check the product and lot details in each record.

• Z-2520-2025 · Jul 17, 2025 · Open, Classified
  Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
• Z-0983-2025 · Nov 26, 2024 · Open, Classified
  Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A