Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2563-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-08-21, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-2563-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-06-11 |
| Classified | 2024-08-12 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 3,694 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450179994, 00884450250846, 00884450280416, 00884450333716 |
| Lot numbers | H2409549, H2414033, H2421264, H2424087, H2437895, H2454187, H2465222, H2471302, H2474035, H2489683, H2500943, H2518365, H2519412, H2519413, H2555399, H2560081, H2583262, H2584710, H2590001, H2596210, H2608380, H2616367, H2641745, H2689450, H2708309, H2718414, H2744000, H2778302, H2791360, H2806045, H2824898, H2825591, H2832445, H2835712, H2836476, H2837641, H2846068, H2849743, H2855331, H2864917 and 12 more |
| Model numbers | K08-02042, K08-02948, K08-03026, K08-03119 |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
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-2563-2024. 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.