Medline medical procedure kits — Class II medical device recall Z-2038-2026
Ongoing recall by Medline Industries, LP, reported 2026-05-06. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medlin
| Recall number | Z-2038-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-30 |
| Reported by FDA | 2026-05-06 |
| Quantity | 1,552,486 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04008019687942, 10080196778942, 10080196879427, 10193489200768, 10193489203325, 10193489203349, 10193489203462, 10193489204070, 10193489204339, 10193489205541, 10193489205794, 10193489208542, 10193489210019, 10193489211573, 10193489211900, 10193489212549, 10193489213904, 10193489214406, 10193489215687, 10193489216158, 10193489217704, 10193489219180, 10193489219746, 10193489219883, 10193489219968 and 475 more |
| Lot numbers | 20LDB444, 20LDB706, 20LMF013, 20LMF345, 20LMF345A, 20LMF494, 20LMF646, 20LMF664, 20XBF607, 20XBG694, 20XBG761, 20XBH580, 20XBH606, 20XBH665, 20XBH717, 20XBH726, 20XBH737, 20XBH763, 20XBH826, 20XBH849, 20XBI152, 20XBI692, 20XBI733, 21ABA047, 21ABA226, 21ABA238, 21ABA248, 21ABA368, 21ABA417, 21ABA646, 21ABB196, 21ABB251, 21ABB322, 21ABB329, 21ABB463, 21ABB838, 21ABB855, 21ABC008, 21ABC047, 21ABC222 and 460 more |
Product
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Reason for recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
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-2038-2026. 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.