Medline medical procedure kits — Class II medical device recall Z-2015-2026

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-2015-2026`
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	3,170 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489285642`, `10193489288384`, `10195327632106`, `40193489285643`, `40193489288385`, `40195327632107`
Lot numbers	`21BBL823`, `21GBL057`, `21IBB479`, `21JBB969`, `21JBZ013`, `21KBX317`, `22ABT749`, `22BBB689`, `22DBP280`, `22DMC612`, `22DMI233`, `22FBD348`, `22GMB685`, `22IBL935`, `22JBF057`, `22KBG029`, `23ABT378`, `23AMD730`, `23DMA094`, `23EBO648`, `23FMF542`, `23IBJ883`, `23IME618`, `23JME739`, `23JMK002`, `23LMF318`, `24AMA230`, `24BMJ374`, `24DMF834`, `24EMD977`, `24FMD882`, `24GMI248`, `24JMJ380`, `25BMB215`, `25DMA861`, `25FMH605`, `25GMK494`, `25HMI678`, `25LMB913`, `26AMH608`

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.

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-2015-2026. 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.