MediHoney® 31815Recalls & reported problems
Acell, Inc. · MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound & Burn Dressing · Class U
All models of MediHoney (16)
Data updated Oct 18, 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
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780486886), received between Mar 7, 2025 and Jun 12, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18, 2026.
Reports received per month
Recalls naming this device
- Jan 16, 2026Class IIOpen, Classified
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1363-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 10, 2025Class IIOpen, Classified
Potential that the induction seal is not completely sealed to the device tube packaging.
Z-1168-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information4
- Unsealed Device Packaging3
Patient problems
- Insufficient Information3
- Bacterial Infection1
- Burning Sensation1
- Fever1
- Inflammation1
- Pain1
- Sepsis1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Insufficient Device Problem Information
A CUSTOMER REPORTED: "THE ITEM WAS GIVEN BY ONE OF THE HOSPITALS. HE HAD SURGERY ON HIS RIGHT LEG. HE USED MEDIHONEY, AND HE GOT THE WOUND CLEANED AND CHECKED. AFTER A MONTH, HE GOT AN INFECTION AND HAD ADDITIONAL SURGERY. HE HAD AN INFECTION AGAIN." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Unspecified Infection
MAUDE report 25485466 ↗InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionMar 28, 2025Unsealed Device Packaging; Unsealed Device Packaging
MalfunctionMar 21, 2025Unsealed Device Packaging; Unsealed Device Packaging
MEDWATCH MW5166202. A CUSTOMER REPORTED THAT THE INDUCTION SEAL OF A MEDIHONEY GEL TUBE WAS NOT SEALED TO TUBE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21664335 ↗MalfunctionMar 21, 2025Unsealed Device Packaging; Unsealed Device Packaging
InjuryMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MEDWATCH REPORT #: MW5165991; MW5165992. IT WAS REPORTED: "MY MOTHER WENT INTO THE HOSPITAL WITH SEVERE SEPSIS AND STAPHYLOCOCCUS EPIDERMIS BACTERIA. PRIOR TO THIS SHE WAS BEING TREATED AT HOME FOR WOUND CARE. THE HOME HEALTH AID WAS USING MEDIHONEY GEL TO TREAT HER WOUNDS AT THE TIME SHE CONTRACTED THE INFECTION. IT WAS DETERMINED THAT THE INFECTION STARTED AT A WOUND ON HER LEG WHERE SHE WAS BEING TREATED WITH THE MEDIHONEY GEL. TODAY I RECEIVED A LETTER FROM CARDINAL HEALTH THAT WAS A NOTICE FOR URGENT MEDICAL RECALL. IT STATES THAT THERE WAS A MANUFACTURING ERROR WITH THE SEAL, AND IT WAS POSSIBLE THAT IT COULD GET CONTAMINATED. IT STATES THE DATE AND LOT LUMBER OF THE MEDIHONEY IN QUESTION OF WHICH I HAVE IN MY POSSESSION AND UNOPENED BOX OF THE PRODUCT THAT MATCHES THE DATE AND LOT NUMBER OF THE PRODUCT IN QUESTION. THE DATES OF USE OF THIS PRODUCT CORRESPOND TO THE TIMES THAT MEDIHONEY WAS ADMINISTERED TO AND SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH THE INFECTION. THIS HAPPENED ON TWO OCCASIONS. ONCE HOME FROM THE HOSPITAL THE FIRST TIME SHE WAS AGAIN ADMINISTERED MEDIHONEY BY THE HOME HEALTH AIDE. SHE AGAIN WAS ADMITTED TO THE HOSPITAL WITH SEPSIS AND A STAPH INFECTION. A
Patient problems: Bacterial Infection; Sepsis
MAUDE report 21547870 ↗
Other Dressing, wound, drug devices
- 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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