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-2016-2026
• Recall Event ID: 98664
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.
• Code Information: Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA668; Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA240; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25IMG470; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMI158; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMC404; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ILA647; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23HLA953; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23GLA064; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ELA715; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22KLB111; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22GLB222; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA384; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA314; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22CLA246; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22BLA951; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ALB037; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA949; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA323; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21JLA776; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21ILA612; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21HLA761; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21CKA431; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21AKA070; Medline Kit Number/SKU DYNJ0750993M: UDI/DI each 10195327196721, UDI/DI case 40195327196722, Lot Number: 22HMA046; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMB856; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMA099; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24KMD499; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24IMH163; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24FMC456; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24EMF287; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24DBR793; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23IMH609; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23FMI503; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23EMF428; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23CMG922; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB904; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB800; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23AMG570; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 22CLA968; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA678; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA280; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23LMA074; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMB808; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23FMG346; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 22JME917; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 25BME921; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24KMI331; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24GMJ067; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24CMD306; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMJ792; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23DMA752; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AMJ467; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AME117; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22LMH958; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22FMI351; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DMG917; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DME926; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME836; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME845; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22AMB811; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21LMC202; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21IMF079; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMG746; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMB707; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21GMA214; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21FMD947; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21EME446; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21DMA825; Medline Kit Number/SKU DYNJ45374F: UDI/DI each 10195327235338, UDI/DI case 40195327235339, Lot Number: 22HLB315; Medline Kit Number/SKU DYNJ48949C: UDI/DI each 10195327506421, UDI/DI case 40195327506422, Lot Number: 24EMG463; Medline Kit Number/SKU DYNJ54242B: UDI/DI each 10195327167097, UDI/DI case 40195327167098, Lot Number: 22EBN455; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22FBC048; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22EBL053; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22ABY741; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21LBR909; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21GBN579; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23FBK303; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23DBJ838; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23BBG277; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 22LBR825; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21HBA373; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21GBK168; Medline Kit Number/SKU DYNJ81423C: UDI/DI each 10195327580971, UDI/DI case 40195327580972, Lot Number: 24ALA997; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25HBG788; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25EBH390; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25DBO029; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24JBJ805; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24IBP006; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 26CMA719; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25KMA819; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25JMI928; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMH651; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMF255; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMC697; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMA738; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24LMF802; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24KMI436; Medline Kit Number/SKU DYNJ904549F: UDI/DI each 10193489296518, UDI/DI case 40193489296519, Lot Number: 21BBN341; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 23KBC207; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24CBF368; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24BBS806; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24KBP901; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS832; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS844; Medline Kit Number/SKU DYNJ906681D: UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25EBT919; Medline Kit Number/SKU DYNJ906681D: UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25EBG758; Medline Kit Number/SKU DYNJ906681D: UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25CBE651; Medline Kit Number/SKU DYNJ906681F: UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 26BBF426; Medline Kit Number/SKU DYNJ906681F: UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 26ABT746; Medline Kit Number/SKU DYNJ906681F: UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 25IBS840; Medline Kit Number/SKU DYNJ906681F: UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 25HBV440; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23KBH640; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23JBS928; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23JBO465; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23IBU560; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23IBW411; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23GBP575; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23GBL027; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23CBP004; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23CBI477; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23ABL781; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23ABF479; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22JBR772; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22IBU581; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22FBP794; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22OBE661; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22OBD412; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25GBX281; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25FBV649; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25DBC300; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25BBQ176; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25ABS828; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24KBR012; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBW006; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBU927; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBD576; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24HBI996; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24HBA457; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24FBE346; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24DBR244; Medline Kit Number/SKU DYNJ907196B: UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23LBI665; Medline Kit Number/SKU DYNJ907196C: UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 26BBU055; Medline Kit Number/SKU DYNJ907196C: UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 26ABP733; Medline Kit Number/SKU DYNJ907196C: UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 25KBN484; Medline Kit Number/SKU DYNJ907196C: UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 25JBM722; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 26BLA610; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA930; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA516; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA196; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25KLA552; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25FLA193; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25DLA774; Medline Kit Number/SKU DYNJ908362F: UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25DLA488; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23JBO029; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23JBC433; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23HBC019; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23GBS064; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23GBJ590; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23CBK565; Medline Kit Number/SKU DYNJ909379: UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23LBF500; Medline Kit Number/SKU DYNJ909379A: UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24FBF086; Medline Kit Number/SKU DYNJ909379A: UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24EBF609; Medline Kit Number/SKU DYNJ909379A: UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24CBK778; Medline Kit Number/SKU DYNJ909379A: UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24BBA312.
• 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: 4016 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.