Medline and Centurion medical procedure kits — Class II medical device recall Z-2021-2026
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-2021-2026 |
|---|---|
| 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 | 486,946 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160254907, 10080196597529, 10080196884704, 10193489201079, 10193489201635, 10193489203790, 10193489204322, 10193489207040, 10193489210514, 10193489211856, 10193489220322, 10193489220889, 10193489231779, 10193489237351, 10193489241860, 10193489242126, 10193489245578, 10193489245707, 10193489253450, 10193489258080, 10193489259902, 10193489261660, 10193489262285, 10193489263060, 10193489265545 and 475 more |
| Lot numbers | 2023052290, 2023070590, 2024080290, 2024100490, 2024122090, 2025032890, 2025082990, 2025122690, 20LKB417, 20LLA634, 20LMF437, 20XBG776, 20XBG842, 20XBH400, 20XBH652, 20XBH715, 21ABA246, 21ABA688, 21ABA774, 21ABB227, 21ABB441, 21ABB768, 21ABB784, 21ABB786, 21ABC107, 21ABC116, 21ABC123, 21ABC144, 21ABC186, 21ABC541, 21ABC802, 21ABC850, 21ABE042, 21ABE270, 21ABE345, 21ABE488, 21ABF026, 21ABF090, 21ABF825, 21ABG153 and 460 more |
Product
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, 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-2021-2026. 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.