Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2567-2024. 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
- 34197 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: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
34197 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: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774…
Every code shown here, 1,995 characters
Catalog Number/UDI-DI code/Lot Numbers: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-03447 00884450192443 H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-03846 00884450144848 H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A 00884450193143 H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP 00884450250426 H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C 00884450816509 H2912500 H2912511 H2912512 H2912513 K12-10056 00884450383704 H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 H2845945 H2866232 H2875176 H2898026 K12-11132B 00884450746530 H2756363 H2762177 H2781251 H2818304 H2832627 H2866135 H2884335 H2931204 K12-12079P 00884450652503 H2760347 H2770070 H2778943 H2798363 H2808227 H2825288 H2838422 H2857759 H2867574 H2897171 H2905369 H2913161 K12-12192P 00884450696118 H2879420 H2885386 K12-12335 00884450716328 H2562551 H2591862 H2607163 H2615042 H2649774 H2705172 H2751359 H2763152 H2772980 H2810502 H2866204 H2871433 H2912338 K12-12382 00884450767702 H2819681 K12M-02489 00884450092873 H2405222 H2520692 H2800145 K12-00443A 00884450190647 H2757679 H2778135 H2796711 H2866277 H2905075 H2915547 H2926391 K12-00657A 00884450190722 H2535655 H2795577 H2810190 K12-01348D 00884450190975 H2383033 H2418832 H2436858 H2451479 H2495639 H2516727 H2520753 H2550062 H2557408 H2599531 H2729229 H2782335 H2836580 H2879389 K12-02111 00884450400517 T2616733 T2653219 T2709061 T2752964 T2821654 T2862633 T2899120 T2932790 K12-02112 00884450400524 T2587406 T2596839 T2653221 T2688030 T2718647…
FDA’s list runs to 4,975 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 4,975 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.