AQUACEL FOAM PRO 421579Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455140510), received between Feb 26, 2026 and Feb 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED BY DISTRIBUTOR THAT A CONTAMINANT HAIR WAS OBSERVED. APPROXIMATELY 28 MILLIMETERS OF BLACK, HAIR LIKE MATERIAL WAS FOUND TRAPPED INSIDE THE PRODUCT. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469089 ↗
• MalfunctionFeb 26, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  IT WAS REPORTED BY DISTRIBUTOR THAT PART OF THE PRIMARY PACKAGE WAS FOUND OPEN. APPROXIMATELY 60 MM (SIXTY MILLIMETER) OF THE SEAL AREA WAS OBSERVED TO BE OPENED AT THE CRIMPED PORTION OF THE PRODUCT. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465995 ↗