Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli

Summary

The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .

Details

Product Description

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.

Lot/Code Info: 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.

Quantity Affected: 4016 kits

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-19

Company