AQUACEL AG FOAM 420629Recalls & reported problems
Convatec, Purchasing Department · AQUACEL FOAM AG ADH 21X21(1X5) NAI · Class U
All models of AQUACEL AG FOAM (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455123797), received between May 1, 2023 and May 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2023Delivered 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 16843204 ↗
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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