Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2562-2024. 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
- 13,560 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: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.
13,560 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331…
Every code shown here, 1,997 characters
Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275 Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495 Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467 Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243 Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930 Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483 Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319 Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892 H2849102 H2854783 H2864807 H2869821 H2911094 H2920493 Catalog Number: K05-01880K UDI-DI code: 00884450250082 Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509 Catalog Number: K05-01890D UDI-DI code: 00884450448465 Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425 Catalog Number: K05-01945A UDI-DI code: 00884450190425…
FDA’s list runs to 3,032 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 3,032 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.