FDA Device recall Z-2565-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste…
- 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: K10/K10-PI (Custom Waste… 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-2565-2024 |
| 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: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.
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/UDI-DI code/Lot Numbers: K10-01722QP 00884450570340 H2410331 H2471342 H2480639 H2502357 H2513044 H25…Catalog Number/UDI-DI code/Lot Numbers: K10-01722QP 00884450570340 H2410331 H2471342 H2480639 H2502357 H2513044 H2525139 H2543652 H2558245 H2564522 H2825008 H2831600 H2875331 H2915643 K10-03220AP 00884450174036 H2406448 H2408885 H2423250 H2428461 H2448942 H2500653 H2536816 H2567302 H2601107 H2623288 H2659637 H2665379 H2708979 H2721135 H2730471 H2760266 H2774855 H2794124 H2812819 H2829027 H2838364 H2843344 H2850151 H2868190 H2872165 H2905227 H2913401 K10-03591KP 00884450380635 H2391366 H2408970 H2441713 H2472906 H2482293 H2491990 H2496930 H2500665 H2518450 H2527822 H2551825 H2567305 H2627298 H2638378 H2645033 H2708977 H2716700 H2730479 H2751466 H2778878 H2784096 H2794135 H2808194 H2821498 H2918877 K10-04291AP 00884450176320 H2352552 H2401233 H2418439 H2431501 H2461658 H2475592 H2492022 H2511077 H2513895 H2518283 H2530047 H2538940 H2551884 H2563710 H2567356 H2641969 H2662164 H2679955 H2713607 H2728230 H2744412 H2785947 H2795948 H2809437 H2818171 H2832163 H2843600 H2866062 |
|---|
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-2565-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.