AQUACEL FOAM PRO 422356Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00768455157310), received between Jul 14, 2023 and Feb 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem

  THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION THE PRODUCT WAS FOUND TO BE DAMAGED. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341839 ↗
• MalfunctionFeb 16, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem

  THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION THE PRODUCT WAS FOUND TO BE DAMAGED. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341838 ↗
• MalfunctionMar 27, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE COMPLAINANT HAD NOTICED A DRAWING ON THE PRODUCT. IT HAD NOT BEEN OPENED OR USED. THE PACKAGE HAD BEEN RECENTLY RECEIVED AT THE SAMPLE WAREHOUSE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706027 ↗
• MalfunctionJul 19, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL CLINICAL NURSE SPECIALIST THAT THE DRESSING HAD AN ABSORBANCE ISSUE AND EVENT WAS IDENTIFIED ON (B)(6) 2023. ITS EVALUATION HAS BEEN RUNNING IN MANY HEALTHCARE CARE PROVIDER FACILITIES AND HAVE RECEIVED NEGATIVE FEEDBACK. THE PRODUCT WAS USED ON PATIENT, HOWEVER, THERE WAS NO HARM REPORTED FOR MALABSORPTION. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349788 ↗
• MalfunctionJul 19, 2023Nonstandard Device; Nonstandard Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349785 ↗
• MalfunctionJul 14, 2023Nonstandard Device; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325355 ↗
• MalfunctionJul 14, 2023Nonstandard Device; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325347 ↗
• MalfunctionJul 14, 2023Nonstandard Device; Nonstandard Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325340 ↗