AQUACEL AG FOAM 420681Recalls & reported problems

Convatec, Purchasing Department · AQUACEL FOAM AG ADH 10X10CM(10PK) NAI · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Convatec AQUACEL Foam wound dressing has 99 adverse event reports, all malfunctions, with no deaths and no injuries. The reports describe contamination, such as brown spots on dressings, an insect found in the packaging, and products delivered unsterile. Most reports say the dressings were never used. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 99
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00768455127153), received between Jun 23, 2022 and Aug 11, 2025 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (99 reports).

1 other recall cover devices cleared under the same FDA submission (K123481); they may or may not involve this specific model.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Contamination /Decontamination Problem99
Delivered as Unsterile Product99
Device Contaminated During Manufacture or Shipping98

Patient problems

No Clinical Signs, Symptoms or Conditions99

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 11, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THE PATIENT HAD OPENED THE PRIMARY PACKAGING AND NOTICED AN INSECT INSIDE. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770133 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032186 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032184 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032150 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032147 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032146 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032145 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032144 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032143 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032142 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032141 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032140 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032137 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032136 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032101 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032099 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032098 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032097 ↗
MalfunctionDec 22, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY RETAILER ABOUT IDENTIFICATION OF VISUAL CONTAMINATION IN THE FORM OF BROWN SPOTS PRESENT ON EVERY DRESSING. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS AND VIDEO WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032096 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON FIVE BOXES (FIFTY DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248186 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON FIVE BOXES (FIFTY DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248183 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON FIVE BOXES (FIFTY DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248174 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON FIVE BOXES (FIFTY DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248173 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON 5 BOXES (50 DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248124 ↗
MalfunctionAug 18, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE NURSE FOUND BLACK SPOTS ON THE DRESSING WHICH SHOULD NOT HAVE BEEN THERE. THIS WAS OBSERVED ON FIVE BOXES (FIFTY DRESSINGS) AND ALL BOXES THAT HAD BEEN TAKEN BY THE SALES REPRESENTATIVE WHO INVOLVED IN CASE WANT TO BE ANALYZED. 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 15248123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123481. One submission often covers many models, so check the product and lot details in each record.

Z-0723-2023 · Nov 15, 2022 · Open, Classified
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Device details

UDI-DI	`00768455127153`
Brand	AQUACEL AG FOAM
Model	420681
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K123481
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Oct 18, 2022

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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