Medline medical procedure kits — Class II medical device recall Z-2025-2026

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-2025-2026`
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	22,116 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489210569`, `10193489239119`, `10193489240894`, `10193489275643`, `10193489338973`, `10193489362060`, `10193489379150`, `10193489419726`, `10193489432718`, `10193489434286`, `10193489460513`, `10193489476606`, `10193489604429`, `10193489618938`, `10193489675108`, `10193489677355`, `10193489688993`, `10193489766202`, `10193489789935`, `10193489825916`, `10193489843408`, `10193489880335`, `10193489893700`, `10193489913187`, `10193489916805` and 179 more
Lot numbers	`21ABC103`, `21ABF228`, `21ABG033`, `21ABH228`, `21ABM493`, `21ABM833`, `21AMA163`, `21BBA803`, `21BBC028`, `21BBF015`, `21BBQ227`, `21BBQ790`, `21BDA755`, `21CBK121`, `21CBW195`, `21CDB258`, `21CDB779`, `21CDC134`, `21CLA152`, `21CLA170`, `21CMB774`, `21DBC693`, `21DBD151`, `21DBE128`, `21DBG641`, `21DBG884`, `21DBM118`, `21DDB137`, `21DKA483`, `21DLA054`, `21DLA305`, `21DMB033`, `21DME180`, `21EBA643`, `21EBC781`, `21EBH572`, `21EDB291`, `21ELA300`, `21EMA403`, `21EMD513` and 460 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)

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-2025-2026. 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.