AQUACEL EXTRA 420673Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00768455125630), received between Dec 23, 2025 and Mar 30, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729852 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729846 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728356 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728351 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728331 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727996 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727906 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727623 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727621 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727591 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727543 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727418 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727224 ↗
• MalfunctionMar 19, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  THE NURSE PRACTITIONER REPORTED THAT THE PACKAGE DID NOT OPEN AT THE INTENDED SEAL AND INSTEAD TORE FROM THE SIDE, WHICH RESULTED IN CONTAMINATION OF THE DRESSING AND REQUIRED IT TO BE DISCARDED. NO UNUSED SAMPLES ARE AVAILABLE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636424 ↗
• MalfunctionMar 19, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE NURSE REPORTED THAT THE PACKAGING COULD NOT BE OPENED WITHOUT TEARING IT APART, WHICH COMPROMISED STERILITY. THE PRODUCT WAS NOT USED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636422 ↗
• MalfunctionJan 9, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  A RESIDENT DOCTOR REPORTED THAT HAIR WAS FOUND IN PRODUCT. THE PRODUCT WAS NOT USED. A VIDEO AND PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016875 ↗
• MalfunctionDec 23, 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 23875787 ↗
• MalfunctionDec 23, 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 23875786 ↗
• MalfunctionDec 23, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874970 ↗