Class IIDeviceOngoing

Medline Industries, LP

Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, Catalog Number: DYNJ54479C; 13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815; 14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C; 15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C; 16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C; 17) SPINAL PACK-LF, Catalog Number: DYNJ67543B; 18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A; 19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098; 20) SPINE, Catalog Number: DYNJ900269I; 21) PACK,CRANIOTOMY, Catalog Number: DYNJ906893C; 22) PACK,CRANIOTOMY, Catalog Number: DYNJ906893D; 23) PACK,CRANIOTOMY, Catalog Number: DYNJ906893F; 24) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192B; 25) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192C; 26) DR MOSHEL CRANI, Catalog Number: DYNJ907920C; 27) SPINE-LF, Catalog Number: DYNJ910956; 28) TOURO OR LAMINECTOMY PACK, Catalog Number: DYNJ912687

Reason for recall

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Details

Recall number: Z-3269-2026
Event ID: 99739
Recall initiated: Aug 10, 2026
Classified: Sep 24, 2026
Reported: Sep 30, 2026
Quantity: 4013 kits
Distribution: US Nationwide.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Northfield, IL, United States
Lot / code info: 1) DYNJT10197, UDI-DI: 10198459778865(each), 40198459778866(case), Lot Number: 26GBA998; 2) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23HLA649; 3) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA935; 4) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA081; 5) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23CLA457; 6) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23BLA516; 7) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22IBO169; 8) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22GBD964; 9) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22DBU156; 10) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24KBH955; 11) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24JBB595; 12) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24GMF624; 13) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24CMJ263; 14) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24BMK244; 15) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24AMF230; 16) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23JBJ151; 17) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23FBG216; 18) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23EBC638; 19) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23CBI768; 20) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABM980; 21) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABI593; 22) DYNJ04342M, UDI-DI: 10193489914672(each), 40193489914673(case), Lot Number: 23HMB096; 23) DYNJ43218G, UDI-DI: 10195327421977(each), 40195327421978(case), Lot Number: 23HMC253; 24) DYNJ46024F, UDI-DI: 10195327237011(each), 40195327237012(case), Lot Number: 23HBJ773; 25) DYNJ46070C, UDI-DI: 10193489853230(each), 40193489853231(case), Lot Number: 23HMC669; 26) DYNJ46672B, UDI-DI: 10889942278909(each), 40889942278900(case), Lot Number: 23HMA338; 27) DYNJ52961I, UDI-DI: 10195327346119(each), 40195327346110(case), Lot Number: 23HBD216; 28) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23CBG270; 29) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23BBB578; 30) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 22LBP140; 31) DYNJ54479C, UDI-DI: 10193489460254(each), 40193489460255(case), Lot Number: 23HBA720; 32) DYNJ57815, UDI-DI: 10889942779437(each), 40889942779438(case), Lot Number: 23HBP930; 33) DYNJ57971C, UDI-DI: 10195327225209(each), 40195327225200(case), Lot Number: 23GBT243; 34) DYNJ59338C, UDI-DI: 10195327021238(each), 40195327021239(case), Lot Number: 23HLA933; 35) DYNJ66742C, UDI-DI: 10195327343156(each), 40195327343157(case), Lot Number: 23GBS430; 36) DYNJ67543B, UDI-DI: 10195327471606(each), 40195327471607(case), Lot Number: 23HBG744; 37) DYNJ69214A, UDI-DI: 10195327184056(each), 40195327184057(case), Lot Number: 23GBR467; 38) DYNJ83098, UDI-DI: 10195327231316(each), 40195327231317(case), Lot Number: 23HMA427; 39) DYNJ900269I, UDI-DI: 10198459569524(each), 40198459569525(case), Lot Number: 26CMI592; 40) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22IBC626; 41) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22HBS240; 42) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMH504; 43) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMD199; 44) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24IMG055; 45) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24GMJ361; 46) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24EMD234; 47) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24DMG428; 48) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24BMI349; 49) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24AMG705; 50) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23LMF389; 51) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMK268; 52) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMB370; 53) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23IMC078; 54) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23HMH387; 55) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23GMD961; 56) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DME252; 57) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DMB260; 58) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23CMG273; 59) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26GMG394; 60) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26FMD545; 61) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMD616; 62) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA441; 63) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA421; 64) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMJ807; 65) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMB625; 66) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25HMI954; 67) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25FMC018; 68) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25EMF909; 69) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25CMF056; 70) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25AMF815; 71) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBW221; 72) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBD210; 73) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25EBM992; 74) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25DBN524; 75) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25BBQ529; 76) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24LBP184; 77) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24KBH441; 78) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24JBD802; 79) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24IBK611; 80) DYNJ907192B, UDI-DI: 24GBX565(each), 10193489946581(case), Lot Number: 40193489946582; 81) DYNJ907192B, UDI-DI: 24FBB829(each), 10193489946581(case), Lot Number: 40193489946582; 82) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24DBV145; 83) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24CBM496; 84) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24ABP283; 85) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23KBN917; 86) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23JBR304; 87) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBU169; 88) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBH841; 89) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23FBH149; 90) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23EBL017; 91) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23CBP523; 92) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF825; 93) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF826; 94) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22JBL437; 95) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA578; 96) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA287; 97) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBI511; 98) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBH553; 99) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26FBR970; 100) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26EBL570; 101) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26DBL401; 102) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26CBD787; 103) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25LBB786; 104) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBQ411; 105) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBH229; 106) DYNJ907920C, UDI-DI: 10198459124839(each), 40198459124830(case), Lot Number: 26DBQ234; 107) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25GMA962; 108) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25CMJ170; 109) DYNJ912687, UDI-DI: 10198459758485(each), 40198459758486(case), Lot Number: 26EBH822