AQUACEL FOAM 421927Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00768455151189), received between Oct 12, 2022 and Jan 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE RETAILER AND END USER COMPLAINED REGARDING THE PRESENCE OF FOREIGN BODY-HAIR IN THE DRESSING. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971409 ↗
• MalfunctionMay 10, 2024Delivered 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 19286007 ↗
• MalfunctionJul 24, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377462 ↗
• MalfunctionJul 24, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376488 ↗
• MalfunctionOct 12, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER BLACK DOT/STRIP INSIDE THE PRIMARY PACKAGE. THE PRODUCT WAS NOT USED ON PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585618 ↗