Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel |
| Quantity | 851,328 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of SINGAPORE, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, DUBAI, CHINA, PANAMA, CANADA, SAUDI ARABIA, BERMUDA, COLOMBIA, MAURITIUS, KUWAIT. |
| Initiated | 2023-05-03 |
| Classified | 2023-06-21 |
| Recall number | Z-1982-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES, LP - Northfield (Z-1982-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92327/
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