Medline recalls TheraHoney wound gel (ref MNK0005/MNK0015) due to sterilization process failure. Affected lots may not meet safety standards. Consumers should check product details and contact Medline for guidance.
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.
Medline is recalling two types of TheraHoney wound gel (ref MNK0005 and MNK0015) because the manufacturer failed to adjust the sterilization dose after a sterilization audit. This could mean the gel isn't properly sterilized and might cause infection.
The recall is due to a sterilization process failure where the manufacturer didn't adjust the dose after a sterilization audit. This could result in the gel not being properly sterilized, potentially leading to infections.
People who own or use TheraHoney wound gel with the listed lot numbers and GTINs are affected. Those with open wounds or using the gel for medical purposes are at higher risk.
Check the product label for the lot numbers listed: LMPTH0189 to LMPTH0213 for ref MNK0005 and LMPTH0188 to LMPTH0212 for ref MNK0015. Also look for the GTIN numbers on the packaging.
Look for the lot numbers and GTINs on the product label to confirm if it's affected.
Medline issued a recall because the manufacturer failed to adjust the sterilization dose after a sterilization audit, which could mean the gel isn't properly sterilized.
Check the product label for the lot numbers and GTINs to see if it's affected. If it is, contact Medline for further instructions.
The recall is due to potential infection risk from improper sterilization, but the official notice does not specify if this causes serious injury.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1982-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-1982-2023 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.