AQUACEL AG+ 422607Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455169566), received between Jun 12, 2024 and May 23, 2025 — classified as 7 malfunctions.

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

• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076306 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A CLINICAL NURSE TO OUR COMPANY REPRESENTATIVE THAT THE ISSUE HAD OCCURRED WITH PATIENT WHO HAD SURGERY FROM AN ORTHOPEDIC SURGEON AT THE HOSPITAL. THE DRESSING WAS REMOVED VIA TAFFY PULL TECHNIQUE IN CLINIC AND A LARGE AMOUNT OF PATCHES OF ADHESIVE RESIDUE REMAINED ADHERED ON THE SKIN. FURTHERMORE, IT WAS REPORTED THAT THE DRESSING WAS DIFFICULT TO REMOVE. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. SKIN WAS PREPPED WITH CHLORHEXIDINE GLUCONATE (CHG) AND IT WAS LEFT TO DRY COMPLETELY BEFORE APPLYING DRESSING, IN THE OPERATING ROOM (OR). DRESSING WAS NOT APPLIED WITH TENSION AND NOT STRETCHED. THE SURGEONS WERE AWARE OF "TAFFY PULL" METHOD AND USED AN ADHESIVE RELEASER. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. THE PRODUCT DID NOT TEAR HER SKIN. NO INJURIES WERE REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076304 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A CLINICAL NURSE TO OUR COMPANY REPRESENTATIVE THAT THE ISSUE HAD OCCURRED WITH PATIENT WHO HAD SURGERY FROM AN ORTHOPEDIC SURGEON AT THE HOSPITAL. THE DRESSING WAS REMOVED VIA TAFFY PULL TECHNIQUE IN CLINIC AND A LARGE AMOUNT OF PATCHES OF ADHESIVE RESIDUE REMAINED ADHERED ON THE SKIN. FURTHERMORE, IT WAS REPORTED THAT THE DRESSING WAS DIFFICULT TO REMOVE. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. SKIN WAS PREPPED WITH CHLORHEXIDINE GLUCONATE (CHG) AND IT WAS LEFT TO DRY COMPLETELY BEFORE APPLYING DRESSING, IN THE OPERATING ROOM (OR). DRESSING WAS NOT APPLIED WITH TENSION AND NOT STRETCHED. THE SURGEONS WERE AWARE OF "TAFFY PULL" METHOD AND USED AN ADHESIVE RELEASER. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. THE PRODUCT DID NOT TEAR HER SKIN. NO INJURIES WERE REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076303 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076302 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076301 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A CLINICAL NURSE TO OUR COMPANY REPRESENTATIVE THAT THE ISSUE HAD OCCURRED WITH PATIENT WHO HAD SURGERY FROM AN ORTHOPEDIC SURGEON AT THE HOSPITAL. THE DRESSING WAS REMOVED VIA TAFFY PULL TECHNIQUE IN CLINIC AND A LARGE AMOUNT OF PATCHES OF ADHESIVE RESIDUE REMAINED ADHERED ON THE SKIN. FURTHERMORE, IT WAS REPORTED THAT THE DRESSING WAS DIFFICULT TO REMOVE. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. SKIN WAS PREPPED WITH CHLORHEXIDINE GLUCONATE (CHG) AND IT WAS LEFT TO DRY COMPLETELY BEFORE APPLYING DRESSING, IN THE OPERATING ROOM (OR). DRESSING WAS NOT APPLIED WITH TENSION AND NOT STRETCHED. THE SURGEONS WERE AWARE OF "TAFFY PULL" METHOD AND USED AN ADHESIVE RELEASER. THE PATIENT HAD TO GO HOME AND SHOWER TO REMOVE RESIDUE. THE PRODUCT DID NOT TEAR HER SKIN. NO INJURIES WERE REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076300 ↗
• MalfunctionJun 12, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  THE DISTRIBUTOR REPORTED THAT, WHEN THE END USER TOOK OUT THE PRIMARY PACKAGE FROM THE BOX, PART OF THE PACKAGING WAS ALREADY OPEN. 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 19517606 ↗