Class 2 Device Recall Medline Neuro Sponge

• Date Initiated by Firm: March 19, 2026
• Date Posted: April 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2017-2026
• Recall Event ID: 98664
• Product Classification: Central venous catheter tray - Product Code OFF
• 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.
• Code Information: 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.
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-359-1704
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors must notify their customers and should include customer quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 3588 kits
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.