MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK — Class II medical device recall Z-0640-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-11, distributed nationwide. Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil wh
| Recall number | Z-0640-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-09 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 12,847 units |
| UPC / GTIN / UDI-DI | 10193489445589, 10193489958058, 10193489994926, 10195327031688, 10195327046057, 10195327072643, 10195327080365, 10195327096458, 10195327105020, 10195327105624, 10195327124786, 10195327127725, 10195327137540, 10195327204150, 10195327216467, 10195327216603, 10195327232580, 10195327239268, 10195327247713, 10195327247959, 10195327265304, 10195327273446, 10195327279721, 10195327286286, 10195327286491 and 65 more |
| Lot numbers | 22EBB077, 22EBB079, 22EBB662, 22EBF993, 22EBN168, 22EBU143, 22EBV250, 22FBF013, 22FBX778, 22FDA475, 22FMD430, 22FMD852, 22FMF883, 22FMG228, 22FMG229, 22FMH471, 22FMH830, 22GBB271, 22GBT930, 22GME200, 22GMF726, 22GMH480, 22HBY426, 22HDA703, 22HMA130, 22HME733, 22IBD332, 22IBS173, 22IDB866, 22IMA512, 22IMA513, 22IMC571, 22IMF886, 22JBN310, 22JBR840, 22JBV775, 22JBW872, 22JBX539, 22JME888, 22JMF457 and 135 more |
| Model numbers | CDS780202P, CDS780202Q, CDS780202R, CDS941061M, CDS981327Q, CDS983186J, DYNJ0038440C, DYNJ0406347M, DYNJ0484186M, DYNJ0484186N, DYNJ0843121K, DYNJ21925S, DYNJ44882L, DYNJ57785B, DYNJ60825B, DYNJ61157C, DYNJ61168C, DYNJ61174C, DYNJ63317C, DYNJ63319D, DYNJ63321D, DYNJ63322A, DYNJ64188B, DYNJ65472B, DYNJ66735A and 20 more |
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 13) NEURO-ORTHO EXTRAS, REF DYNJ44882L; 14) NEURO PACK, REF DYNJ57785B; 15) NEURO PACK, REF DYNJ60825B; 16) CHRISTUS MC NEURO PACK, REF DYNJ61157C; 17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C; 18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C; 19) AFCH SHUNT, REF DYNJ63317C; 20) NEURO SPINE PK, REF DYNJ63319D; 21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D; 22) DBS PACK, REF DYNJ63322A; 23) NEURO LAM, REF DYNJ64188B; 24) PACK,V-P SHUNT, REF DYNJ65472B; 25) NEURO PK, REF DYNJ66735A; 26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B; 27) NEURO PACK, REF DYNJ68558A; 28) NEURO PACK, REF DYNJ69019C; 29) VP SHUNT, REF DYNJ81866A; 30) VP SHUNT, REF DYNJ81866B; 31) VP SHUNT, REF DYNJ81866C; 32) NEURO PACK, REF DYNJ84058A; 33) NEURO, REF DYNJ900420O; 34) CRANIO / NEURO / SPINE, REF DYNJ901072G; 35) CRANIO / NEURO / SPINE, REF DYNJ901072I; 36) LAMINECTOMY, REF DYNJ903870F; 37) MINOR NEURO, REF DYNJ904859C; 38) MINOR NEURO, REF DYNJ904859D; 39) MINOR NEURO, REF DYNJ904859F; 40) NEURO, REF DYNJ904861B; 41) NEURO, REF DYNJ904861D; 42) NEURO, REF DYNJ904861F; 43) NEURO, REF DYNJ904861G; 44) KIT V P SHUNT, REF DYNJ908835A; 45) GENERAL NEURO, REF DYNJ909744
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0640-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.