AQUACEL AG+ 422604Recalls & reported problems
Convatec, Purchasing Department · Aquacel® Ag Advantage Surgical Advanced Antimicrobial Dressing With Silver 3.5X6" (9X15Cm) · Class U
All models of AQUACEL AG+ (9)
Data updated Oct 16, 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 00768455169535), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Delivered as Unsterile Product1
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.
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 ↗
Other Dressing, Wound, Drug devices
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- 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 DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- MEDLINE MNK0005Medline 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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