Medline medical procedure kits — Class II medical device recall Z-2024-2026

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-2024-2026`
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	2,153 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489219722`, `10193489231670`, `10193489292183`, `10193489356113`, `10193489766486`, `10193489798616`, `10193489798852`, `40193489219723`, `40193489231671`, `40193489292184`, `40193489356114`, `40193489766487`, `40193489798617`, `40193489798853`
Lot numbers	`21ABL492`, `21AMB081`, `21BBB024`, `21BBE213`, `21CBI323`, `21CBY739`, `21CMC668`, `21DBA613`, `21DBU812`, `21EBE932`, `21EBS624`, `21EMD626`, `21FBJ190`, `21GBJ251`, `21GMB555`, `21IBM004`, `21IBU411`, `21IMC184`, `21JBX107`, `21JMF409`, `21KBD492`, `21KBF463`, `21KBO873`, `21KBO877`, `21KBP591`, `21KBT464`, `21LBD683`, `21LBG900`, `21LMC822`, `22ABA711`, `22ABB461`, `22ABB463`, `22ABJ346`, `22AMD386`, `22BBT747`, `22BBZ713`, `22BBZ714`, `22EBE987`, `22FBM378`, `22FBV579` and 17 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.

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-2024-2026. 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.