Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2568-2024. 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
- 103369 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: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H K12T-03638H K12T-03706A K12T-03746C K12T-03788 K12T-03839H K12T-03853C K12T-03866B K12T-03867A K12T-03868 K12T-03868A K12T-04068 K12T-04106D K12T-04106F K12T-04140J K12T-04586D K12T-04697 K12T-04959B K12T-04963A K12T-05061J K12T-05081D K12T-05093D K12T-05281C K12T-05334D K12T-05423G K12T-05442B K12T-05472H K12T-05559B K12T-05824G K12T-05824H K12T-05825H K12T-05926C K12T-05991A K12T-06033C K12T-06211B K12T-06250 K12T-06282 K12T-06374D K12T-06416A K12T-06561A K12T-06640C K12T-06732A K12T-06783B K12T-06819C K12T-06979B K12T-07003A K12T-07008G K12T-07088 K12T-07266A K12T-07305 K12T-07556C K12T-07614A K12T-07729A K12T-07845B K12T-07893B K12T-08003 K12T-08565A K12T-08614B K12T-08727B K12T-08801 K12T-08867 K12T-09267D K12T-09337A K12T-09438A K12T-09523A K12T-09595 K12T-09685 K12T-09875 K12T-09880A K12T-09889 K12T-09974A K12T-10167A K12T-10287 K12T-10338H K12T-10409 K12T-10733 K12T-11467 K12T-11524A K12T-12152A K12T-12456 K22C-00001 K22C-00001A K22C-00034 K22C-00035 K22C-00042 K22C-00043 K22C-00052 K22C-00053A K22C-00054A K22C-00056 K22C-00058A K22C-00059 K22C-00062A K22C-00064A K22C-00069 K22C-00069A K22C-00070 K22C-11010 To support various vascular or cardiac diagnostic and interventional procedures.
103369 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: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H…
Every code shown here, 1,989 characters
Catalog Number/UDI-DI code/Lot Numbers: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H 00884450782934 T2779744 T2823401 T2865508 T2909943 K12T-01822 00884450048849 T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635 K12T-01852L 00884450390641 T2627432 K12T-02006J 00884450410912 T2803003 T2866385 T2872131 K12T-02054 00884450048917 T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324 K12T-02091G 00884450265925 T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566 K12T-02102B 00884450352861 T2597046 T2637278 T2662098 T2697333 T2751272 T2844211 K12T-02309 00884450055007 T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935 K12T-02392A 00884450242926 T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265 T2637343 T2702608 T2776001 T2803012 T2821648 T2899061 K12T-02416 00884450238684 T2232553 K12T-02510N 00884450558522 T2616294 T2644061 T2776005 T2816289 T2886448 K12T-02725G 00884450278260 T2194607 T2303611 T2351004 T2408869 K12T-02725H 00884450679500 T2489997 T2587462 T2614079 T2655947 T2700183 T2713211 T2761550 T2781048 T2807148 T2906805 K12T-02890K 00884450242209 T2475031 T2570328 T2605749 T2626141 T2677852 T2704266 T2780036 T2803017 T2821647 T2823617 T2900194 K12T-02949A 00884450049211 T2449187 T2643784 K12T-03012C 00884450518328 T2232391 T2271357 T2305988 T2430292 T2540019 T2549960 T2560554 T2710204 T2776052 T2805520 K12T-03014B 00884450518533 T2193400 T2262009 T2283036 T2329184 T2428130 T2470356 T2540243 T2549961 T2560555 T2605751 T2697359 T2718786 T2805521 T2817191 T2899049…
FDA’s list runs to 13,916 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 13,916 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.