Medline medical procedure kits — Class II medical device recall Z-2034-2026

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-2034-2026`
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	4,324 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489815122`, `10193489846058`, `10195327040284`, `10195327154738`, `10195327276041`, `40193489815123`, `40193489846059`, `40195327040285`, `40195327154739`, `40195327276042`
Lot numbers	`21AKA471`, `21CKA503`, `21EBP877`, `21EBP891`, `21GBW057`, `21GBW059`, `21GMD367`, `21HMB278`, `21HMG136`, `21IMF752`, `21JMF667`, `21KBG927`, `21LBN774`, `21LMA406`, `21LMA805`, `21WBA306`, `22ABD653`, `22ABO417`, `22ABW137`, `22CMB218`, `22CMB219`, `22CMI117`, `22DBU479`, `22EBE351`, `22EMB486`, `22FBX502`, `22FBY332`, `22GBG766`, `22HBB560`, `22IBD321`, `22IBJ001`, `22LBA177`, `22LBJ888`, `23ABD998`, `23BBE825`, `23CBF699`, `23CBI861`, `23CBX731`, `23DBG858`, `23EBO916` and 18 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.

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-2034-2026. 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.