FDAClass IIMay 6, 2026

Medline medical procedure kits recall: Endotoxin

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.

Why was Medline medical procedure kits recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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 40193489201391, Lot Number : 22FBH340; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21CKA561; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21BKA591; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21AKB149; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23KBE105; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23JBH870; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23IBS256; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23HBW099; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23EBB384; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 22JBP897; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABI491; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABG881; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABH208; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABF236; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABB836; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21KMH013; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JME705; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JMD611; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21IME971; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26BME412; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26AMJ494; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25KMG940; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25GMH433; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23KBN958; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23JBH478; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23HBT146; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23GBG624; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23CBC001; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABU575; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABL787; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBM663; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBJ926; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22JBG520; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22IBR340; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22EBU759; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22DBR774; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ813; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ792; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21KBG387; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21IBR350; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21GBV108; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21FBJ559; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21DBE602; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21CBJ874; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBI620; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBA242; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25JBD488; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25HBM158; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25GBE204; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25EBR912; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25BBU542; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25ABW421; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24KBO504; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24JBM902; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24IBK100; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24GBE540; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24FBK645; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24DBS967; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24BBG984; Medline Kit Number/SKU DYNJ56819G: UDI/DI each 10195327073749, UDI/DI case 40195327073740, Lot Number : 22HBB961; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21KLA936; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21JLA574; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21HLA401; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLB120; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA452; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA295; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21CLA652; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23IMI021; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24HMA726; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24GMI771; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24DMB264; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23KMJ671; Medline Kit Number/SKU DYNJ68213F: UDI/DI each 10198459501173, UDI/DI case 40198459501174, Lot Number : 25IMD349; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23GBI579; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 24ABL755; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23LBC527; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22CDC077; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADC035; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADB161; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADA979; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21LDA084; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21HDB299; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21DDC112; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21ADC003.

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.
Recalling firm
Medline Industries, LP
Quantity
3588 kits
Distribution
Worldwide distribution.
Recall date
May 6, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls