MEDLINE MNK0005Recalls & reported problems
Medline Industries, Inc. · DRESSING,HONEY,THERAHONEY,.5 OZ TUBE · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389161562), received between Sep 9, 2026 and Sep 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 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
- May 3, 2023Open, Classified
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
Z-1982-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Product Quality Problem2
- Burst Container or Vessel1
- Fluid/Blood Leak1
- Gel Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916648 ↗MalfunctionSep 22, 2026Gel Leak
It was reported that when foil is removed from tubes large quantity of honey gel squirts from tube without squeezing tube. wastes product and makes a mess on tube.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854357 ↗MalfunctionSep 21, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838836 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693495 ↗MalfunctionSep 9, 2026Product Quality Problem
It was reported that the dressing ¿doesn¿t stay on patient, different consistency than others.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691842 ↗
Other Dressing, wound, drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- 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 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 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