Medline procedure kits labeled as: 1) DELIVERY PACK — Class II medical device recall Z-1446-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-1446-2025 |
|---|---|
| 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 | 2025-02-11 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,958 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10193489215649, 10193489382730, 10193489923094, 10193489923506, 10193489967371, 10195327148232, 10195327234416, 10195327430481, 10888277049444, 10889942099634, 10889942323081, 10889942853731, 40193489215640, 40193489382731, 40193489923095, 40193489923507, 40193489967372, 40195327148233, 40195327234417, 40195327430482, 40888277049445, 40889942099635, 40889942323082, 40889942853732 |
| Lot numbers | 20JKB018A, 21EBN038A, 21IMH700A, 21JMG530A, 21LMG173A, 22CMB444A, 22IBG256Z, 22JMB827A, 22LBE104A, 23HMC532A, 23IMF243A, 23IMF426A |
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 for recall
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.
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-1446-2025. 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.