Recall Z-3269-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-10
- Firm location
- Northfield, IL, United States
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
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.
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