MediHoney® 31805Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780486978), received between Jan 24, 2025 and Jun 26, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

Recalls naming this device

1. 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 ↗

2. May 25, 2022Class IIIOpen, 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 problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathMay 22, 2026Insufficient Device Problem Information

  N/A

  Patient problems: Unspecified Infection

  MAUDE report 25255088 ↗
• 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 ↗
• 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 ↗