Medline medical procedure kits — Class II medical device recall Z-2037-2026

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-2037-2026`
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	3,290 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489355284`, `10193489853896`, `10195327112554`, `10195327260019`, `10195327320836`, `10195327370107`, `10195327370442`, `10195327447564`, `10195327460648`, `10195327575731`, `10198459131752`, `10198459229725`, `40193489355285`, `40193489853897`, `40195327112555`, `40195327260010`, `40195327320837`, `40195327370108`, `40195327370443`, `40195327447565`, `40195327460649`, `40195327575732`, `40198459131753`, `40198459229726`
Lot numbers	`21CBJ936`, `21DBU602`, `21FMA440`, `21GME747`, `21HMD139`, `21IMC497`, `21JMC829`, `22DMC340`, `22FME241`, `22GBL794`, `22IBN801`, `22IBO842`, `22IBP260`, `22LMD749`, `23ABI841`, `23CBD302`, `23CMA495`, `23CMB048`, `23DBC239`, `23EBE141`, `23EBW204`, `23FBA458`, `23FBB413`, `23FBN621`, `23FBP153`, `23GBK387`, `23HMH413`, `23HMI877`, `23IBC227`, `23IBE948`, `23IBG214`, `23IBW005`, `23JBA275`, `23KBO017`, `23KBU302`, `23KBX879`, `23LBE522`, `23LBH320`, `23LBL498`, `24ABA089` and 53 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.

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-2037-2026. 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.