FDA Device recall Z-0626-2025
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0626-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Identifiers
| code_info | 1) REF DYNJ00281O, UDI/DI 10193489962963 (each) 40193489962964 (case), Lot Numbers: 22KMA417, 22FMD671; 2) REF DYNJ…1) REF DYNJ00281O, UDI/DI 10193489962963 (each) 40193489962964 (case), Lot Numbers: 22KMA417, 22FMD671; 2) REF DYNJ0101291F, UDI/DI 10195327286644 (each) 40195327286645 (case), Lot Numbers: 23FDA396, 23HDA759, 23EDB388, 23LDB909; 3) REF DYNJ0488546K, UDI/DI 10195327505097 (each) 40195327505098 (case), Lot Numbers: 23IBP983; 4) REF DYNJ84762, UDI/DI 10195327413088 (each) 40195327413089 (case), Lot Numbers: 23IMA327, 23IMA727; 5) REF DYNJ906907C, UDI/DI 10195327376819 (each) 40195327376810 (case), Lot Numbers: 23DBM940, 23FBG165, 23IBQ680 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0626-2025%22
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