AQUACEL AG BURN 403786Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455124121), received between Feb 3, 2025 and Jun 10, 2025 — 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.

• MalfunctionJun 10, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179170 ↗
• MalfunctionJun 10, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  THE PRODUCT SPECIALIST, REPORTING ON BEHALF OF KNOWN HOSPITAL, NOTED THAT UPON OPENING THE BOX, THE CUSTOMER DISCOVERED THAT FOUR PIECES HAD INCOMPLETE SEALS. THIS CAUSED THE ITEMS TO BE EXPOSED TO OUTSIDE AIR, RENDERING THEM UNSTERILIZED. OUT OF THE FIVE PIECES IN THE BOX, ONLY ONE PIECE REMAINED COMPLETELY SEALED. THE EDGES OF THE PACKAGE ENVELOPE WERE STILL STRAIGHT AND EVENLY ALIGNED, INDICATING NO HAND CUTTING BY THE CUSTOMER. ADDITIONALLY, THE SIZE OF THE ENVELOPE WAS CONSISTENT WITH THAT OF A COMPLETELY INTACT ONE. THIS WAS THE SECOND TIME THE CUSTOMER DETECTED A SIMILAR ISSUE FROM THE SAME BATCH BUT A DIFFERENT BOX. THE PHOTOGRAPHS ARE ALSO AVAILABLE DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179169 ↗
• MalfunctionJun 10, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  THE PRODUCT SPECIALIST, REPORTING ON BEHALF OF KNOWN HOSPITAL, NOTED THAT UPON OPENING THE BOX, THE CUSTOMER DISCOVERED THAT FOUR PIECES HAD INCOMPLETE SEALS. THIS CAUSED THE ITEMS TO BE EXPOSED TO OUTSIDE AIR, RENDERING THEM UNSTERILIZED. OUT OF THE FIVE PIECES IN THE BOX, ONLY ONE PIECE REMAINED COMPLETELY SEALED. THE EDGES OF THE PACKAGE ENVELOPE WERE STILL STRAIGHT AND EVENLY ALIGNED, INDICATING NO HAND CUTTING BY THE CUSTOMER. ADDITIONALLY, THE SIZE OF THE ENVELOPE WAS CONSISTENT WITH THAT OF A COMPLETELY INTACT ONE. THIS WAS THE SECOND TIME THE CUSTOMER DETECTED A SIMILAR ISSUE FROM THE SAME BATCH BUT A DIFFERENT BOX. THE PHOTOGRAPHS ARE ALSO AVAILABLE DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179155 ↗
• MalfunctionJun 10, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179154 ↗
• MalfunctionFeb 3, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  IT WAS REPORTED BY THE PRODUCT SPECIALIST ON BEHALF OF THE HOSPITAL THAT WHEN OPENING THE BOX, THE END USER FOUND THAT TWO PIECES (2 PCS) OF DRESSINGS HAD INCOMPLETE SEALS, WHICH HAD CAUSED THE ITEMS TO BE EXPOSED TO OUTSIDE AIR AND MAKING THEM NON-STERILE. IT WAS FURTHER CLARIFIED THAT THERE HAD BEEN NO TEARING MARK TO OPEN THE ENVELOPE, THE EDGE OF THE PACKAGE HAD REMAINED STRAIGHT AND EVENLY ALIGNED, AND THE SIZE HAD BEEN THE SAME AS THE SEAL DRESSING. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291718 ↗
• MalfunctionFeb 3, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  IT WAS REPORTED BY THE PRODUCT SPECIALIST ON BEHALF OF THE HOSPITAL THAT WHEN OPENING THE BOX, THE END USER FOUND THAT TWO PIECES (2 PCS) OF DRESSINGS HAD INCOMPLETE SEALS, WHICH HAD CAUSED THE ITEMS TO BE EXPOSED TO OUTSIDE AIR AND MAKING THEM NON-STERILE. IT WAS FURTHER CLARIFIED THAT THERE HAD BEEN NO TEARING MARK TO OPEN THE ENVELOPE, THE EDGE OF THE PACKAGE HAD REMAINED STRAIGHT AND EVENLY ALIGNED, AND THE SIZE HAD BEEN THE SAME AS THE SEAL DRESSING. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291135 ↗