AQUACEL AG FOAM 420805Recalls & reported problems
Convatec, Purchasing Department · AQUACEL FOAM AG ADH 8X8CM 1X10 NAI · Class U
All models of AQUACEL AG FOAM (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00768455129126), received between Aug 14, 2018 and May 24, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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
Most reported problems
Device problems
- Delivered as Unsterile Product5
- Contamination /Decontamination Problem2
- Packaging Problem2
- Unsealed Device Packaging2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THERE WAS PRODUCT DISCOLORATION (STAIN) ON DRESSING. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391785 ↗MalfunctionMay 24, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THERE WAS PRODUCT DISCOLORATION (STAIN) ON DRESSING. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391782 ↗MalfunctionMar 23, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIMARY PACKAGE WAS OPENED. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869030 ↗MalfunctionMar 23, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIMARY PACKAGE WAS OPENED. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869016 ↗MalfunctionAug 14, 2018Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material
NO FURTHER ACTION REQUIRED BY MEDICAL EVALUATORS. MEDICAL REVIEWER EDITS NEEDED.
Patient problems: No Patient Involvement
MAUDE report 7781931 ↗
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, ClassifiedConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Other Dressing, Wound, Drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
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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