FDA Device recall Z-2562-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit),…
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit),… by Merit Medical Systems, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2562-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-11 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-D…Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275 Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495 Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467 Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243 Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930 Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2562-2024%22
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