MediHoney® 31515Recalls & reported problems
Acell, Inc. · MEDIHONEY® Dressing with Active Leptospermum Honey Wound and Burn Dressing · Class U
All models of MediHoney (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780486824), received between Oct 4, 2024 and Dec 27, 2024 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Aug 5, 2025Class IIOpen, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2506-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 13, 2024Class IIOpen, Classified
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Z-0054-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information5
- Material Integrity Problem1
Patient problems
- Unspecified Infection4
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A CUSTOMER REPORTED AN INFECTION AFTER MEDIHONEY (ID 31515) USE FOR AN OPEN WOUND. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Unspecified Infection
MAUDE report 21031168 ↗InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionOct 4, 2024Material Integrity Problem; Material Integrity Problem
Other Dressing, wound, drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 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 DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- SteriCare Solutions 6270Nurse Assist, 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page