AQUACEL AG+ 422606Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455169559), received between Jan 31, 2023 and Jan 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 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 24016876 ↗
• MalfunctionJan 31, 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 16270218 ↗
• MalfunctionJan 31, 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 16270216 ↗
• MalfunctionJan 31, 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 16270214 ↗
• MalfunctionJan 31, 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 16270213 ↗
• MalfunctionJan 31, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

  THE EMDR IS BEING SUBMITTED FOR FIVE COMPANY¿S DRESSINGS FROM ONE MARKET UNIT WITH UNSEALED PACKAGING CAUSING THE PRODUCT TO FALL OUT OF THE SECONDARY PACKAGING. IT WAS REPORTED BY A REPRESENTATIVE FROM SURGICAL SUITE TO THE COMPANY¿S SALES REPRESENTATIVE THAT WHEN THEY WENT TO USE THE DRESSING, AFTER OPENING THE PACKAGE FROM THE END WITH THE ARROW, THE DRESSING FELL OUT FROM THE OPPOSITE END DUE TO THE PACKAGING NOT BEING HEAT SEALED PROPERLY AT THE OTHER END. THE PRODUCT WAS NOT USED ON PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE OBTAINED BY COMPANY¿S SALES REPRESENTATIVE AND SENT TO COMPANY'S PRODUCT MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270212 ↗