Medline medical procedure kits — Class II medical device recall Z-2036-2026

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-2036-2026`
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	7,004 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489586725`, `10884389201640`, `10889942469659`, `10889942840724`, `10889942841721`, `40193489586726`, `40884389201641`, `40889942469650`, `40889942840725`, `40889942841722`
Lot numbers	`21ABD741`, `21DBG514`, `21DBI879`, `21EBA373`, `21FBQ973`, `21GBJ471`, `21HBM832`, `21IBG464`, `21IBL547`, `21IBX286`, `21IMD775`, `21KBZ291`, `21KMD114`, `21LBM539`, `22BBJ540`, `22CBA050`, `22DBE203`, `22DBT428`, `22EBG751`, `22FBA057`, `22FMI371`, `22GBW568`, `22IBM433`, `22JBI096`, `22JBU430`, `22NBF066`, `23ABR478`, `23BBO048`, `23CBH452`, `23CBP725`, `23DBT199`, `23EBD017`, `23EBR984`, `23EBT579`, `23GBM279`, `23GBQ615`, `23HBY508`, `23IBQ007`, `23JBD782`, `23LBI949` and 13 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.

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-2036-2026. 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.