Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2562-2024
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-2562-2024 |
|---|---|
| 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 | 13,560 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450136850, 00884450138229, 00884450138519, 00884450139240, 00884450139325, 00884450141915, 00884450160596, 00884450190425, 00884450200643, 00884450250082, 00884450271773, 00884450273470, 00884450298350, 00884450312049, 00884450394502, 00884450448465, 00884450450253, 00884450450260, 00884450543115, 00884450639511 |
| Lot numbers | H2348365, H2353310, H2362663, H2369280, H2382003, H2383009, H2385672, H2385684, H2390242, H2393542, H2397922, H2397984, H2398231, H2398244, H2404146S1, H2410692, H2412414, H2412868, H2412975, H2415380, H2415389, H2416155, H2420188, H2420219, H2426797, H2427243, H2429834, H2430164, H2436679, H2443286, H2443304, H2446029, H2446096, H2450076, H2450196, H2450827, H2451023, H2454819, H2454910, H2466702 and 146 more |
| Model numbers | K05-00203M, K05-00511J, K05-00547J, K05-00612Q, K05-00819A, K05-01030H, K05-01274D, K05-01646, K05-01688A, K05-01717B, K05-01880K, K05-01890D, K05-01945A, K05-01954A, K05-02247A, K05-02436B, K05-02507, K05-02511A, K05-02954, K05-02982A |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.
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-2562-2024. 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.