Halyard 42306Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651423068), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 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.

• InjuryApr 11, 2024Material Puncture/Hole; Material Puncture/Hole

  STAFF OPENED THE DRAPES ASEPTICALLY USING THE INNER WRAPPER. WHEN THEY CHECKED THE INNER WRAPPER (CSR WRAP) FOR HOLES THEY FOUND PIN HOLES IN THE WRAPPER. THIS CONTAMINATED THE WHOLE BACK TABLE AND CAUSED A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094110 ↗

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