Medline medical procedure kits — Class II medical device recall Z-2017-2026
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-2017-2026 |
|---|---|
| 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 | 3,588 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489201390, 10193489215205, 10193489222432, 10193489242553, 10193489283273, 10193489477511, 10193489767032, 10193489822540, 10193489860740, 10193489896541, 10195327073749, 10195327371845, 10195327511999, 10198459433559, 10198459501173, 40193489201391, 40193489215206, 40193489222433, 40193489242554, 40193489283274, 40193489477512, 40193489767033, 40193489822541, 40193489860741, 40193489896542 and 5 more |
| Lot numbers | 21ABB836, 21ABF236, 21ABG881, 21ABH208, 21ABI491, 21ADC003, 21AKB149, 21BKA591, 21CBJ874, 21CKA561, 21CLA652, 21DBE602, 21DBG187, 21DDC112, 21FBC630, 21FBI072, 21FBJ559, 21GBA846, 21GBE684, 21GBN290, 21GBV108, 21GLA295, 21GLA452, 21GLB120, 21HBA351, 21HBE520, 21HBE521, 21HBH244, 21HDB299, 21HLA401, 21IBM934, 21IBP593, 21IBR350, 21IME971, 21JBE527, 21JLA574, 21JMD611, 21JME705, 21KBE066, 21KBG387 and 78 more |
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.
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-2017-2026. 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.