Halyard 77823Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651778236), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Adhesive Too Strong” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 27, 2026Adhesive Too Strong

  THE ADHESIVE STRIP SURROUNDING THE FENESTRATED DRAPE OPENING REMAINED ADHERED TO THE PROTECTIVE BACKING. THE ASSISTANT EXPERIENCED DIFFICULTY REMOVING IT, RESULTING IN TEARING OF THE ADHESIVE STRIP DURING REMOVAL. THE DRAPE WAS NO LONGER FUNCTIONAL IN THAT IT COULD NOT BE ADHERED TO THE SURGICAL SITE. THE USER CONTINUED TO UTILIZE FOR REMAINDER OF PROCEDURE. THERE WAS NO PATIENT HARM ACCORDING TO REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303016 ↗

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