Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF — Class II medical device recall Z-1449-2025
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-1449-2025 |
|---|---|
| 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 | 268 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10193489395204, 10193489863918, 10193489984170, 10195327092139, 10195327107499, 40193489395205, 40193489863919, 40193489984171, 40195327092130, 40195327107490 |
| Lot numbers | 21GMA889A, 21IBP928Z, 22CDB491A, 23EMD924A, 23JBW085A |
Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q
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-1449-2025. 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.