MEDLINE THERAHONEY GEL — Class II medical device recall Z-1982-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-06-28, distributed nationwide. Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization d
| Recall number | Z-1982-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-05-03 |
| Classified | 2023-06-21 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BM, CA, CN, CO, DO, KW, PA, SA, SG |
| Quantity | 851,328 units |
| UPC / GTIN / UDI-DI | 30884389161566, 40884389154558 |
| Lot numbers | LMPTH0188, LMPTH0189, LMPTH0190, LMPTH0191, LMPTH0192, LMPTH0193, LMPTH0195, LMPTH0196, LMPTH0197, LMPTH0198, LMPTH0199, LMPTH0200, LMPTH0201, LMPTH0202, LMPTH0203, LMPTH0204, LMPTH0205, LMPTH0206, LMPTH0207, LMPTH0210, LMPTH0210B, LMPTH0211, LMPTH0212, LMPTH0213 |
| Model numbers | MNK0005, MNK0015 |
Product
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1982-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.