Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2558-2024
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-2558-2024 |
|---|---|
| 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 | 11,837 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450409435, 00884450421093, 00884450426388, 00884450602102, 00884450820605 |
| Lot numbers | K12T-09284D, K12T-10621, K12T-10773, K12T-10800, K12T-12491, T2209872, T2220946, T2280633, T2308653, T2344516, T2359067, T2364198, T2407018, T2411888, T2428905, T2429939, T2448507, T2452908, T2473123, T2498967, T2503204, T2508160, T2531706, T2597113, T2611405, T2629759, T2643484, T2653268, T2674429, T2680463, T2685014, T2691082, T2705035, T2715028, T2744136, T2776727, T2794927, T2800155, T2800379, T2824129 and 6 more |
| Model numbers | K12T-09284D, K12T-10621, K12T-10773, K12T-10800, K12T-12491 |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 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-2558-2024. 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.