AQUACEL AG+Recalls & reported problems across all models

We found 9 models of AQUACEL AG+ by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Jan 9, 2026 — classified as 5 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AQUACEL AG+ problems

AQUACEL AG+ models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AQUACEL AG 412011

  Dressing, Wound, Drug
  13 reports
• AQUACEL AG+ 422607

  Dressing, Wound, Drug
  7 reports
• AQUACEL AG 412010

  Dressing, Wound, Drug
  6 reports
• AQUACEL AG+ 422606

  Dressing, Wound, Drug
  6 reports
• AQUACEL AG 412012

  Dressing, Wound, Drug
  4 reports
• AQUACEL AG+ 413570

  Dressing, Wound, Drug
  3 reports
• AQUACEL AG 420670

  Dressing, Wound, Drug
  1 report
• AQUACEL AG+ 413571

  Dressing, Wound, Drug
  1 report
• AQUACEL AG+ 422604

  Dressing, Wound, Drug
  1 report

Recent AQUACEL AG+ adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 27, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE MEDICAL CENTER NOTIFIED THE COMPANY'S TERRITORY MANAGER ABOUT THE ISSUE. UPON OPENING THE DRESSING, ONE OF THE STAFF MEMBERS NOTICED A HAIR EMBEDDED BETWEEN THE OUTER HYDROFIBER LAYER AND POLYURETHANE COATING OF SURGICAL DRESSING. THE HAIR WAS INDEED EMBEDDED INTO THE DRESSING AND COULD NOT BE REMOVED FROM THE TOP OR BRUSHED AWAY. THE DRESSING WAS NOT APPLIED TO THE PATIENT. THE TERRITORY MANAGER RETAINED THE DRESSING AND OFFERED TO MAIL IT FOR FURTHER INVESTIGATION. THE VOICE MESSAGE WAS ALSO ATTACHED BY THE TERRITORY MANAGER. THE PHOTOGRAPHS OF THE DRESSING WERE ALSO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343538 ↗
• 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 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705828 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705826 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705824 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705823 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705822 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705175 ↗
• MalfunctionMar 27, 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 DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705174 ↗

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