Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2579-2024. Published in FDA’s Enforcement Report on Aug 21, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 21, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 1,753,625 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 K10T-01428A K10T-01785L K10T-02735D K10T-03122A K10T-03348K K10T-03627F K10T-03627G K10T-03627H K10T-03776F K10T-03776G K10T-03784 K10T-03810A K10T-03810B K10T-03979M K10T-04060G K10T-04113Q K10T-04113R K10T-04160R K10T-04163H K10T-04199C K10T-04200C K10T-04256H K10T-04338G K10T-04415K K10T-04463D K10T-04500B K10T-04578B K10T-04655B K10T-04718F K10T-04723B K10T-04744D K10T-04774D K10T-04775 K10T-04780 K10T-04806A K10T-04844N K10T-04861B K10T-04862 K10T-04892 K10T-04983B K10T-04986F K10T-05012G K10T-05012H K10T-05081F K10T-05082G K10T-05165A K10T-05197B K10T-05219 K10T-05272C K10T-05307B K10T-05308B K10T-05365A K10T-05366B K10T-05367 K10T-05397 K10T-05451N K10T-05451R K10T-05462 K10T-05493B K10T-05504C K10T-05518 K10T-05531 K10T-05541C K10T-05541D K10T-05592B K10T-05593C K10T-05612 K10T-05651B K10T-05655 K10T-05662 K10T-05665A K10T-05666 K10T-05666A K10T-05667F K10T-05667G K10T-05667H K10T-05670B K10T-05711A K10T-05711B K10T-05746A K10T-05747A K10T-05797 K10T-05812A K10T-05817 K10T-05819
1,753,625 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 418,572 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- 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
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 11, 2024.
- FDA classified it on Aug 12, 2024.
- FDA’s Enforcement Report published it on Aug 21, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Merit Medical Systems, Inc., of South Jordan, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 418,572 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.