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.

Class II

Recalling firm: Medline Industries, LP
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.
Affected products (lot / model / serial): Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBW804; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBX015; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBD094; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23IBQ501; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23FBO564; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23EBW686; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23DBO524; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22GBU281; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBR456; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBM213; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBN031; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22DBP331; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22MBA145; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22ABM907; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21KBE066; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21JBE527; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBH244; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE520; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE521; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21FBC630; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22IBU058; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22HBH306; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22GBQ912; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBT185; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBI063; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21IBM934; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21GBN290; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21DBG187; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21IBP593; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21HBA351; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBE684; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBA846; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21FBI072; Medline Kit Number/SKU DYNJ04592K: UDI/DI each 10193489215205, UDI/DI case 40193489215206, Lot Number : 23JLA230; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 401
Units affected: 3588 kits
Distribution pattern: Worldwide distribution.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-2017-2026
Recall initiated: March 19, 2026
FDA classification date: April 30, 2026
FDA report date: May 6, 2026
FDA event ID: 98664
Last updated on HTM Vibe: July 24, 2026

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