Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2567-2024
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-2567-2024 |
|---|---|
| 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 | 34,197 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450092873, 00884450144848, 00884450161821, 00884450190647, 00884450190722, 00884450190975, 00884450191309, 00884450191422, 00884450192412, 00884450192443, 00884450193143, 00884450194133, 00884450205051, 00884450234372, 00884450250426, 00884450259290, 00884450278048, 00884450281611, 00884450383704, 00884450391051, 00884450394816, 00884450400517, 00884450400524, 00884450410257, 00884450443927 and 18 more |
| Lot numbers | H2383033, H2386248, H2390923, H2396335, H2398739, H2399243, H2404130, H2405222, H2405752, H2406238, H2406446, H2407774, H2408589, H2408722, H2413469, H2413516, H2414054, H2414114, H2418283, H2418284, H2418341, H2418369, H2418832, H2421061, H2421065, H2423209, H2423279, H2428435, H2430266, H2436858, H2437885, H2439003, H2440852, H2440872, H2447205, H2448761, H2448853, H2451479, H2451626, H2457285 and 429 more |
| Model numbers | K12-00443A, K12-00657A, K12-01348D, K12-02097B, K12-02111, K12-02112, K12-02489A, K12-03438, K12-03447, K12-03846, K12-04185A, K12-04262BP, K12-05494, K12-05576G, K12-05805A, K12-06318, K12-06509A, K12-06509B, K12-07208A, K12-07299P, K12-08303, K12-08716, K12-09009, K12-09098C, K12-10056 and 18 more |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B 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-2567-2024. 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.