Medline procedure kits labeled as: 1) ANGIO PACK — Class II medical device recall Z-1436-2025
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-1436-2025 |
|---|---|
| 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 | 1,939 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10193489223712, 10193489329698, 10193489505634, 10193489541106, 10193489648614, 10193489651119, 10193489785753, 10884389722145, 10888277011298, 10889942429370, 10889942474639, 10889942745746, 10889942802012, 10889942806683, 10889942965021, 40193489223713, 40193489329699, 40193489505635, 40193489541107, 40193489648615, 40193489651110, 40193489785754, 40884389722146, 40888277011299, 40889942429371 and 5 more |
| Lot numbers | 20BDB393A, 20FBN798A, 21AMA569A, 21BBG490A, 21BBI114A, 21GMA850A, 21GMB606A, 21HBP134A, 21IMD296A, 21IME955A, 23BBS889A, 23CLA070A, 23EBE428A, 23EBE560A, 23LBU921Z |
Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873; 7) ANGIOGRAPHY PACK, Pack Number DYNJ57498; 8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A; 9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I; 10) ANGIOGRAPHY TRAY-LF, Pack Number DYNJ58722A; 11) CATH LAB PACK, Pack Number DYNJ42912F; 12) CATH LAB PK, Pack Number DYNJ35643B; 13) CATH PACK-LF, Pack Number DYNJ0367643Q; 14) CRMS ANGIO PACK-LF, Pack Number PHS616026002A; 15) DEPAUL ANGIO CATH PACK, Pack Number DYNJ24542L
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-1436-2025. 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.