FDAFDA · Food and drugs·Recall number Z-3269-2026
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
Published September 30, 2026 · Recall initiated: August 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide.
- Lot
- 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) DYNJ90
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3269-2026 on September 30, 2026. Reported hazard: 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.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
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