Recall archive / FDA device enforcement
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus... — FDA record Z-2579-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T-02272H K05T-02515A K05T-02533 K05T-02728 K05T-02733C K05T-03153 K05T-03201 K09T-00318D K09T-07304G K09T-07627L K09T-07627M K09T-08747 K09T-08774F K09T-08952 K09T-09037J K09T-09358 K09T-09576J K09T-09760C K09T-09978A K09T-10485L K09T-10728H K09T-10728J K09T-11022C K09T-11022D K09T-11379F K09T-11430B K09T-11478A K09T-11738D K09T-11798 K09T-11875B K09T-12020B K09T-12020C K09T-12200 K09T-12538F K09T-12538G K09T-12883B K09T-12883C K09T-12942B K09T-12942C K09T-12942D K09T-12942F K09T-12970B K09T-13293 K09T-13293A K09T-13294 K09T-13294A K09T-13384B K09T-13384C K09T-13444B K09T-13459A K09T-13459B K09T-13681A K09T-13740 K09T-13927 K09T-13927A K09T-13949 K09T-13972 K09T-14025 K09T-14028B K09T-14035 K09T-14072 K09T-14218 K10T-01528G K10T-01528H K10T-03769F K10T-04233J K10T-04941B K10T-05595A K10T-05611B K10T-05680B K10T-06085 K10T-06085A K10T-06101 K10T-12092 K10T-12092A K12-05727F K12T-01737D K12T-01816A K12T-01996K K12T-02064 K12T-02285F K12T-02667A K12T-02703C K12T-02703F K12T-02911F K12T-02911G K12T-02940 K12T-03196 K12T-03312 K12T-03724F K12T-03933C K12T-03975A K12T-03979C K12T-04085 K12T-04270A K12T-04271B K12T-04348A K12T-04383G K12T-04707 K12T-04926G K12T-05302D K12T-05303D K12T-05303F K12T-05327D K12T-05432F K12T-05432G K12T-05627 K12T-05849C K12T-05849D K12T-05849F K12T-05850B K12T-05850C K12T-05903B K12T-05968D K12T-05974A K12T-05996M K12T-05996N K12T-06043 K12T-06313B K12T-06412A K12T-06431A K12T-06436 K12T-06694A K12T-06821 K12T-06826 K12T-06839A K12T-07986C K12T-08071C K12T-08071D K12T-08072D K12T-08072F K12T-08166D K12T-08703 K12T-08964F K12T-09013F K12T-09237A K12T-09292A K12T-09338D K12T-09456B K12T-09840B K12T-10464 K12T-10514A K12T-10515 K12T-10515A K12T-10516 K12T-10562 K12T-10583A K12T-10586A K12T-10649 K12T-10664A K12T-10881B K12T-11049 K12T-11151 K12T-11586 K12T-11626B K12T-11626C K12T-11680 K12T-11684 K12T-11826 K12T-11853P K12T-11857B K12T-11880 K12T-11880A K12T-11880B K12T-11901 K12T-11903 K12T-11910 K12T-11923 K12T-11923A K12T-11924A K12T-11925A K12T-11943B K12T-11943C K12T-11984 K12T-11985 K12T-11996 K12T-12017 K12T-12091 K12T-12138 K12T-12149 K12T-12153 K12T-12155 K12T-12155A K12T-12155B K12T-12157 K12T-12157A K12T-12157B K12T-12224 K12T-12224A K12T-12224B K12T-12230 K12T-12242 K12T-12242A K12T-12244 K12T-12285A K12T-12291 K12T-12291A K12T-12323 K12T-12331A K12T-12397 K12T-12403 K12T-12406 K12T-12406A K12T-12407 K12T-12419 K12T-12448 K12T-12448A K12T-12494 K12T-11210 K12T-12321 K20T-00002 K20T-00004A K20T-00012 K20T-00016A K20T-00019 K20T-00027 K20T-00031 K20T-00035 K12T-02045 K12T-02909 K12T-03993A K12T-06280 K12T-09329A K12T-09368A K12T-10157 K12T-12095 K05T-01920F K09T-10485M K09T-14028 K09T-14028A K10-04922C K10T-00554J K10T-00554L K10T-00861D K1...
- 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.
- Classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1,753,625 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2579-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number/UDI-DI code/Lot Numbers: TKITS-CI K05-02166B 00884450499597 T2199559 T2241078 T2282965 T2314787 T2449229 T2350723 T2408151 T2865497 T2490391 T2434206 T2495447 T2549930 T2587249 T2542280 T2718618 T2643306 T2687167 T2762714 T2779728 T2805456 T2823368 T2853484 K05T-00380C 00884450286999 T2428876 T2445382 T2465777 T2505820 T2614851 T2479555 T2560483 T2587250 T2636525 T2697344 T2730359 T2916415 T2745227 T2779731 T2792255 T2805457 T2842259 T2865498 K05T-01674B 00884450140796 T2390906 T2425906 T2453860 T2823388 T2800974 T2774647 T2853488 T2899143 K05T-01863 00884450315347 T2317007 T2397063S T2366145 T2425907 T2470012 T2587251 T2505851 T2533799 T2525473 T2623832 T2625813 T2718633 T2762715 T2805459 T2823390 T2863782 T2910718 K05T-01941C 00884450235386 T2363422 T2390908 T2428877 T2466078 T2495453 T2548913 T2597012 T2584604 T2687170 T2652469 T2627880 T2712308 T2779868 T2753061 T2899028 T2866724 T2816242 K05T-01955 00884450140826 T2345281 T2399661 T2464322 T2470005 T2386001 T2587403 T2765333 T2643557 T2719601 T2823391 T2861459 K05T-02138 00884450140833 T2313700 T2349568 T2363423 T2386669 T2621412 T2479311 T2533804 T2549003 T2745251 T2726918 T2716870 K05T-02159 00884450140840 T2397995 T2561788 T2417859 T2434208 T2509792 T2801089 T2762716 T2549931 T2625814 T2675576 T2893877 K05T-02272G 00884450684023 T2708057 T2448644 T2479556 T2549932 T2525579 T2536595 T2643308 T2587252 T2596738 T2675577 T2726919 T2774653 T2759596 T2810448 T2843256 T2800975 K05T-02272H 00884450814710 T2871522 T2898650 K05T-02515A 00884450255797 T2246086 T2295357 T2317021 T2355732 T2708058 T2434420 T2436222 T2464320 T2479677 T2498901 T2550150 T2584606 T2602771 T2596837 T2774655 T2643558 T2800976 T2667623 T2682131 T2849520 T2842263 T2823393 T2895062 T2898651 K05T-02533 00884450255803 T2470008 T2390909 T2417860 T2509879 T2525626 T2698958 T2620280 T2876922 T2718634 T2849216 T2809725 T2909932 T2899055 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02733C 00884450410813 T2223646 T2495463 T2315211 T2342954 T2322340 T2333496 T2536600 T2397194 T2407260 T2418130 T2428881 T2449669 T2697342 T2587431 T2623833 T2627379 T2676794 T2738103 T2708061 T2773344 T2818284 T2823759 T2876928 T2898652 T2931544 K05T-03153 00884450463796 T2407053 T2408155 T2442952 T2479713 T2542359 T2788780 T2587555 T2675580 T2748985 T2850760 T2816275 K05T-03201 00884450547915 T2327701 T2349571 T2625815 T2390910 T2470017 T2489182 T2533261 T2762719 T2549934 T2718635 T2690357 T2656028 T2823394 K09T-00318D 00884450388389 T2300861 T2329688 T2349572 T2370009 T2386003 T2403812 T2442953 T2495464 T2550789 T2521167 T2521168 T2680870 K09T-07304G 00884450671948 T2400947 T2407054 T2479715 T2447477 T2525636 T2541147 T2635779 T2676810 T2662054 T2708067 T2781718 T2833070 T2861463 K09T-07627L 00884450336151 T2428888 T2436257 T2457838 T2495467 T2550678 T2627380 T2572024 T2517476 T2652496 T2738109 T2676813 T2643765 T2699225 T2800993 T2587432 K09T-07627M 00884450794616 T2807076 T2816853 T2871586 T2933811 T2832466 K09T-08747 00884450411582 T2448462 T2299466 T2322585 T2417966 T2329405 T2360363 T2646157 T2382188 T2386672 T2403854 T2864506 T2434457 T2471545 T2849271 T2781172 T2697320 T2909806 T2560720 T2538556 T2585644 T2657322 T2587557 T2781183 T2748988 T2712889 T2779900 T2811085 K09T-08774F 00884450242957 T2700125 T2700174 T2721142 T2408157 T2745276 T2843278 T2779902 T2864507 T2465907 T2537746 T2550622 T2599043 T2643845 T2599045 T2676822 K09T-08952 00884450048139 T2636529 K09T-09037J 00884450268575 T2647476 T2805972 T2709965 T2832139 T2680800 T2758211 T2718873 T2779930 T2800997 T2827650 T2850767 T2899091 K09T-09358 00884450048160 T2643752 T2596904 T2676841 T2774730 T2807079 T2712336 T2687178 T2635782 T2813397 T2842463 K09T-09576J 00884450264942 T2708078 T2614920 K09T-09760C 00884450356883 T2550681 T2495503 T2340130 T2408160 T2457860 T2495502 T2906066 T2825544S T2861306 T2551388 T2576362 T2596861 T2594515 T2652504 T2890713 T2773341 T2699226 T2801006 T2816386 K09T-09978A 00884450387733 T2389864 K09T-10485L 00884450479346 T2333962 K09T-10728H 00884450486290 T2299757 T2349143 T2350033 T2370015 T2414731 T2428909 T2399783 T2676859 T2707467 T2773363 T2636546 T2449672 T2479986 T2723021 T2792303 T2525684 T2550683 T2551442 T2587437 T2823769 K09T-10728J 00884450821503 T2905920 T2918279 K09T-11022C 00884450388440 T2366226 T2386674 T2465609 T2414736 T2452710 T2428910 T2636552 T2499632 T2525696 T2525697 T2587561 T2626063 T2646163 T2576000 K09T-11022D 00884450777909 T2811153 T2779939 T2860467 T2740344 T2853503 T2805977 T2861336 K09T-11379F 00884450290682 T2314761 T2322587 T2403966 K09T-11430B 00884450332191 T2223657 T2278316 T2315213 T2360396 T2499025 T2390915 T2407263 T2435079 T2512481 T2525707 T2550690 T2699229 T2587439 T2643767 T2699230 T2854455 T2738115 T2781185 T2801013 T2823772 T2898973 K09T-11478A 00884450229446 T2494453 T2435073 T2492160 T2531649 T2556857 T2615000 T2627391 T2647509 T2776358 T2697332 T2801015 T2849284 T2864585 T2918282 K09T-11738D 00884450571903 T2281935 T2310866 T2317059 T2350037 T2386675 T2407062 T2428915 T2457870 T2479724 T2536659 T2581322 T2550181 T2652527 T2595210 T2633414 T2786071 T2660481 T2700135 T2823535 T2753073 T2676897 T2697313 T2876235 T2832142 T2910720 K09T-11798 00884450391945 T2366468 T2428921 T2860052 T2449764 T2495544 K09T-11875B 00884450337035 T2241306 T2241388 T2266306 T2266307 T2382380 T2397197 T2418135 T2492162 T2662259 T2847961 K09T-12020B 00884450337066 T2307603 T2318412 T2329692 T2626458 T2399794 T2643738 T2432648 T2436497 T2477357 T2516137 T2566156 T2587515 T2733788 T2738191 T2657597 T2700136 T2818675 T2801027 K09T-12020C 00884450782736 T2807336 T2867311 T2847962 T2832566 T2901793 T2929258 T2906122 K09T-12200 00884450263358 T2525743 T2457874 T2550691 T2732947 T2655945 T2712378 T2906137 T2847967 T2816358 T2773334 K09T-12538F 00884450600740 T2536714 T2549936 T2511923 T2536391 K09T-12538G 00884450720318 T2566182 T2609539 T2697329 T2712044 T2729330 T2800944 T2773324 T2881143 T2864592 K09T-12883B 00884450436820 T2219765 T2256703 T2278116 K09T-12883C 00884450651711 T2428965 T2536728 T2354376 T2366234 T2414784 T2511926 T2554949 T2576129 T2550184 T2587564 T2680893 T2628709 T2639079 T2754397 T2732930 T2718880 K09T-12942B 00884450471272 T2301020 T2322851 T2360406 T2386676 T2449386 T2443102 T2412118 T2445157 K09T-12942C 00884450689882 T2523903S T2474174 T2499074 T2523903 T2561851 T2536738 K09T-12942D 00884450728970 T2627394 T2650341 T2671527 T2602591 T2624736 T2712298 T2666398 K09T-12942F 00884450772546 T2786082 T2738543 T2752216 T2854497 T2819034 T2818684 T2881525 T2901795 T2933805 T2917957 K09T-12970B 00884450483053 T2885536 T2832571 T2824590 T2842451 K09T-13293 00884450641712 T2339960 T2428968 T2407063 K09T-13293A 00884450692509 T2480958 T2499008 T2543189 T2647604 T2587565 T2850787 T2792313 T2550187 T2489376 T2626069 T2697370 T2774990 T2816299 T2895211 T2823542 T2901851 K09T-13294 00884450641729 T2339961 T2407064 T2428970 K09T-13294A 00884450692516 T2677626 T2480980 T2779942 T2871662 T2499009 T2609786 T2587566 T2525907 T2697315 T2716659 T2862020 T2816300 T2792314 T2899881 T2885272 K09T-13384B 00884450584347 T2330900 T2407264 K09T-13384C 00884450682913 T2448827 T2466023 T2866379 T2838004 T2805987 T2542579 T2549028 T2866382 T2903881 T2597025 T2571771 T2697319 T2636581 T2727012 T2776359 K09T-13444B 00884450533123 T2295562 T2278359 T2313749 T2490835 T2474196 T2587516 T2615152 T2635755 T2531644 T2636582 T2670722 T2699170 T2774993 T2708953 T2813399 T2823750 T2901852 K09T-13459A 00884450708729 T2584633 T2614036 K09T-13459B 00884450744505 T2639152 T2847979 T2667824 T2734956 T2774995 T2667827 T2814327 T2816436 T2895212 T2931539 K09T-13681A 00884450611104 T2609540 T2584647 K09T-13740 00884450574379 T2283315 T2314960 T2355736 T2412155 T2436992 T2550190 T2667842 T2773369 T2571753 T2609787 T2736362 T2816439 T2781737 T2876244 K09T-13927 00884450655900 T2383210 T2408150 T2443107 T2485273 T2499003 T2525945 T2587570S T2550192 T2635751 T2637288 T2606434 K09T-13927A 00884450744512 T2662073 T2712893 T2779944 T2761301 T2801881 T2823546 T2843390 T2850789 T2876248 T2898696 K09T-13949 00884450663905 T2399821 T2536870 K09T-13972 00884450668733 T2407640 T2898697 T2479727 T2676948 T2417975 T2587571 T2606435 T2712894 T2823547 T2753075 T2850790 T2801092 T2876249 T2918340 K09T-14025 00884450698105 T2511835 T2587572 T2550193 T2525947 T2658311 T2849272 T2700146 T2716662 T2901855 T2746575 T2762838 T2876251 K09T-14028B 00884450751114 T2676953 T2849291 T2762839 K09T-14035 00884450720387 T2609789 T2554963 T2672345 T2576304 T2736363 T2587573 T2805994 K09T-14072 00884450731918 T2612331 T2600363 T2823776 T2754609S T2612334 T2772994 T2743265S T2738119 T2766979 T2809848 T2717534 T2788918 K09T-14218 00884450816417 T2901856 K10T-01528G 00884450335185 T2166214 T2351640 T2299513 T2327707 T2435080 T2397200 T2496548 T2492450 T2687351 T2643775 T2536891 T2587444 T2738121 T2781030 T2823782 K10T-01528H 00884450815113 T2917988 T2872011 K10T-03769F 00884450290675 T2199997 T2232531 T2268992 T2295581 T2299470 T2360504 K10T-04233J 00884450585924 T2205564 T2802010 T2306123 T2323017 T2385199 T2407069 T2425253 T2437115 T2466312 T2496626 T2666114 T2528380 T2599064 T2595390 T2697345 T2775451 T2899096 T2816441 T2862474 K10T-04941B 00884450232866 T2643991 T2690349 T2712900 T2814360 T2779966 T2909809 T2832154 K10T-05595A 00884450337301 T2550734 T2366409 T2390946 T2437263 T2443573 T2479138 T2499024 T2584673 T2427551 T2596871 T2643780 T2700177 T2713206 T2766987 T2822310 T2927079 T2807131 K10T-05611B 00884450412596 T2262344 T2587455 T2340075 T2351647 T2527779 T2429288 T2449694 T2386113 T2497967 T2543215 T2566321 T2723018 T2627428 T2677669 T2707244 T2753457 K10T-05680B 00884450600580 T2198119 T2262116 T2443596 T2407077 T2498022 T2581481 T2537868 T2662091 T2884169 K10T-06085 00884450696309 T2499016 T2527871 T2550251 K10T-06085A 00884450727508 T2637217 T2577227 T2677698 T2702166 T2709915 T2802961 T2895286 T2823791 T2918493 K10T-06101 00884450778319 T2902757 K10T-12092 00884450635360 T2466076 T2417991 T2527872 T2363630 T2550256 K10T-12092A 00884450730515 T2609824 T2626133 T2709060 T2779995 T2850814 T2648097 T2595580 T2814947 T2773370 T2832179 T2871317 T2898842 K12-05727F 00884450391013 T2609830 T2709065 K12T-01737D 00884450268001 T2306138 T2415832 T2415920 T2458546 T2550257 T2489442 T2528645 T2680614 T2662092 T2626137 T2597044 T2570340 T2906782 T2806089 T2793201 T2875226 T2855745 K12T-01816A 00884450352724 T2645397 T2656033 T2677746 T2701921 T2718781 T2751255 T2765427 T2793236 T2840602 T2899016 T2865510 T2909946 K12T-01996K 00884450268476 T2844195 T2933602 T2587588 T2682311 T2733384 T2751259 K12T-02064 00884450352854 T2371549 T2781046 T2899039 T2834069 T2738159 T2680875 T2443653 T2498656 T2499078 T2637274 T2617287 T2572077 T2581517 K12T-02285F 00884450310809 T2135572 T2193366 T2205623 T2234282 T2296096 T2329180 T2379317 T2391091 T2430198 T2406800 T2457354 T2498855 T2505848 T2528873 T2549951 T2585625 T2560500 T2625830 T2643320 T2736211 T2656037 T2680388 T2783122 T2751332 T2803009 T2823410 T2863424 T2872136 K12T-02667A 00884450049112 T2305986 T2323769 T2339902 T2412600 T2415328 T2437763 T2464269 T2643324 T2596067 T2569568 T2549956 T2762745 T2842335 T2816486 T2846617 T2881539 K12T-02703C 00884450585917 T2385062 T2385061 K12T-02703F 00884450682036 T2755742 T2849139 T2803015 T2779752 T2816409 T2458749 T2520365 T2520366 T2466360 T2624432 T25... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 21, 2024
- Recall initiation date
- Jun 11, 2024
- Center classification date
- Aug 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.