AQUACEL FOAM 421557Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455142224), received between Dec 23, 2025 and Aug 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158207 ↗
• MalfunctionJan 15, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077842 ↗
• MalfunctionJan 15, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077840 ↗
• MalfunctionJan 15, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077822 ↗
• MalfunctionJan 15, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT DURING THE INBOUND INSPECTION, SPOTS WITH DIFFERENT COLOR WERE IDENTIFIED ON THE PRODUCT SURFACE OF FOUR DRESSINGS. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077818 ↗
• MalfunctionJan 14, 2026Delivered as Unsterile Product; Device Damaged Prior to Use; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065739 ↗
• MalfunctionDec 23, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874879 ↗