MediHoneyRecalls & reported problems across all models
Acell, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
12 open recalls name at least one MediHoney model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls
- 12
We found 16 models of MediHoney by Acell, Inc. in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2024 and Jul 17, 2026 — classified as 1 death, 13 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).
12 FDA recall records name at least one of these models by its device identifier, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MediHoney recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 16, 2026Open, Classified
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1364-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jan 16, 2026Open, Classified
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1363-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2511-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2510-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2509-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2508-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2507-2025 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2506-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2505-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 10, 2025Open, 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 ↗
- Sep 13, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Z-1803-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported MediHoney problems
Device problems
- Insufficient Device Problem Information13
- Unsealed Device Packaging3
- Material Discolored2
- Material Integrity Problem1
Patient problems
- Unspecified Infection8
- Insufficient Information5
- Impaired Healing2
- Bacterial Infection1
- Burn(s)1
- Burning Sensation1
- Fever1
- Inflammation1
MediHoney models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MediHoney® 31815Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Dressing, wound, drug2 recalls0 reports
- MediHoney® 31505Dressing, wound, drug1 recall1 report
- MediHoney® 31622Dressing, wound, drug1 recall0 reports
- MediHoney® 31644Dressing, wound, drug1 recall0 reports
- MediHoney® 31620Dressing, wound, drug1 recall0 reports
- MediHoney® 31722Dressing, wound, drug1 recall0 reports
- MediHoney® 31640Dressing, wound, drug1 recall0 reports
- MediHoney® 31720Dressing, wound, drug1 recall0 reports
- MediHoney® 31012Dressing, wound, drug1 recall0 reports
- MediHoney® 31022Dressing, wound, drug1 recall0 reports
- MediHoney® 31045Dressing, wound, drug1 recall0 reports
- MediHoney® 31612Dressing, wound, drug1 recall0 reports
- MediHoney® 31738Dressing, wound, drug1 recall0 reports
Recent MediHoney adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 17, 2026Insufficient Device Problem Information
A CUSTOMER REPORTED INFECTION AND A SERIES OF SURGERIES THAT ENDED UP WITH AMPUTATION OF TWO TOES WITH BONES AFTER MEDIHONEY USE DUE TO DIABETIC ULCER OF RIGHT MIDFOOT ASSOCIATED WITH TYPE 2 DIABETES MELLITUS. MEDICAL ASSESSMENT.
Patient problems: Unspecified Infection
MAUDE report 25855715 ↗MalfunctionJun 26, 2026Material Discolored
A CUSTOMER REPORTED: "I WAS ISSUED A TUBE OF MEDIHONEY FROM K. URGENT CARE WHEN I HAD A KNEE WOUND THAT NEEDED THE APPLICATION. I KEPT THE TUBE, FIGURING IT HADN¿T EXPIRED. I GOT A CUT ON MY HAND AND TRIED TO USE THE PRODUCT, AND IT WAS BROWN INSTEAD OF YELLOW. I REALIZED THE CAP OF THE TUBE KEEPS TURNING, AS THOUGH THE TUBE ITSELF IS SEPARATED FROM THE NOZZLE. THE EXPIRATION DATE IS 2026-07-01." ADDITIONAL INFORMATION: WHAT WAS THE DATE OF THE FIRST APPLICATION TO YOUR KNEE WOUND? "5 MAR 2025" WAS THE MEDIHONEY ONLY USED FOR ONE TIME? "IT WAS USED UNTIL THE WOUND CLOSED. I FOUND OUT IT WAS A BROKEN TUBE WHEN I DECIDED TO TRY AND USE IT ON A WOUND I GOT ON MY HAND RECENTLY. THE GEL IS A DARK BROWN (NOT YELLOW, LIKE IT WAS ORIGINALLY)." DID A HEALTHCARE PROFESSIONAL APPLY THE PRODUCT, OR DID YOU APPLY IT YOURSELF AT HOME? "THE FIRST TIME, THEY APPLIED IT AT URGENT CARE, BUT THEY TOLD ME HOW TO APPLY IT AT HOME."
Patient problems: Insufficient Information
MAUDE report 25638168 ↗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 ↗DeathMay 22, 2026Insufficient Device Problem Information
InjuryFeb 27, 2026Insufficient Device Problem Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3005920706-2026-00007. IT WAS REPORTED THAT WHILE USING MEDIHONEY (ID 31805), THE PATIENT DEVELOPED INFECTION. TWO TUBES WERE USED: ONE WAS PROVIDED BY THE HOSPITAL, THE OTHER WAS ACQUIRED IN A PHARMACY.
Patient problems: Unspecified Infection
MAUDE report 24469586 ↗InjuryFeb 27, 2026Insufficient Device Problem Information
A CUSTOMER REPORTED HAVING A SURGERY ON HER LEFT FOOT (THIRD TOE) ON (B)(6) 2025. IT WAS ALL INFECTED AND SHE WAS DIRECTED BY HER DOCTOR TO BUY MEDIHONEY AND AFTER MEDIHONEY USE, THE TOE HAD AN OPEN WOUND IN (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Impaired Healing
MAUDE report 24469572 ↗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 ↗InjuryJan 24, 2025Material Discolored; Material Discolored
A CUSTOMER REPORTED A MEDIHONEY GEL TUBE (ID 31805) BECAME DARK BROWN AFTER A WEEK OF USAGE AND "WOUND OPEN UP AND BECAME UGLY". THE MEDIHONEY WAS PRESCRIBED BY HIS FOOT DOCTOR, AND HE VISITED HIS DOCTOR WEEKLY FOR A PERIOD OF A MONTH. THE PRODUCT WAS KEPT IN A COOL PLACE IN HIS ROOM. THE PRODUCT WAS PREPARED BY CLEANING IT AFTER A SHOWER, APPLYING IT WITH A Q-TIP, AND COVERING IT WITH A NON-STICK SMALL GAUGE. CURRENTLY, THE WOUND IS MUCH SMALLER AND STILL DRAINING A BIT, AND HE WAS PRESCRIBED WITH ANOTHER CREAM, COLLAGENASE SANTILLANA OINTMENT.
Patient problems: Impaired Healing
MAUDE report 21231539 ↗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
Other Acell, Inc. products
All Acell, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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