Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Nu

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; by Medline Industries, LP. Reason: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may pre.

Details

Product Description

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

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

Quantity Affected: 4013 kits

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-08-10

Company