FDA Device recall Z-1446-2025
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016 by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1446-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Identifiers
| code_info | 1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number…1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case), Lot Number 21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case), Lot Number 21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case), Lot Number 22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case), Lot Number 23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case), Lot Number 22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case), Lot Number 23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case), Lot Number 22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case), Lot Number 22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 408899428 |
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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-1446-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.