Medline medical procedure kits — Class II medical device recall Z-2020-2026

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-2020-2026`
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	1,294 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489219098`, `10193489426021`, `10193489577402`, `10193489715163`, `10193489945645`, `10198459589348`, `40193489219099`, `40193489426022`, `40193489577403`, `40193489715164`, `40193489945646`, `40198459589349`
Lot numbers	`21ABF008`, `21BMB155`, `21CMB708`, `21DBP964`, `21DDB294`, `21DDB913`, `21EBC912`, `21EBN493`, `21EMB698`, `21FBB400`, `21FBQ527`, `21GMD919`, `21HBF657`, `21IBE910`, `21IBM809`, `21IDA884`, `21IME243`, `21JBJ185`, `21KBM498`, `21KDB891`, `21OBA488`, `22ABF773`, `22BBH011`, `22BDB470`, `22EBQ566`, `22FBW392`, `22FDA247`, `22OBB247`, `22OBM500`, `23BBB609`, `23EBD035`, `23FBJ867`, `23GBS485`, `23KBP837`, `24BBU360`, `24EBA930`, `24GBY270`, `24KBJ090`, `24LBN800`, `25DBF266` and 5 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.

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-2020-2026. 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.