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

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-2026-2026`
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	9,805 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10195327112721`, `10195327213978`, `10195327228842`, `10195327326159`, `10195327622381`, `10198459210662`, `10198459253348`, `10198459281693`, `10198459417436`, `10198459503870`, `10198459626258`, `40195327112722`, `40195327213979`, `40195327228843`, `40195327326150`, `40195327622382`, `40198459210663`, `40198459253349`, `40198459281694`, `40198459417437`, `40198459503871`, `40198459626259`
Lot numbers	`22FBB472`, `22GBS127`, `22HBH553`, `22JBR211`, `23BBB952`, `23BBC125`, `23CMD903`, `23EME227`, `23FME285`, `23GMG136`, `23HMG291`, `23IMC591`, `23JMB211`, `23JMK023`, `23KMI415`, `24AMH016`, `24BMD229`, `24CMI441`, `24FMG130`, `24GBE890`, `24HMF066`, `24JBE518`, `24JBV969`, `24JMG571`, `24KBB462`, `24KBJ163`, `24KBR868`, `24KMH419`, `24KMI915`, `24LMD726`, `25ABD635`, `25BBA593`, `25BBC547`, `25BBK629`, `25CBD819`, `25CME067`, `25CME296`, `25DBB435`, `25DBD392`, `25DBG176` and 26 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

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-2026-2026. 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.