Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2564-2024. 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
- 188837 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: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.
188837 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog…
Every code shown here, 1,992 characters
Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog Number: K09-00807AH UDI-DI code: 00884450742365 Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 Catalog Number: K09-01467AD UDI-DI code: 00884450282441 Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 Catalog Number: K09-01467AF UDI-DI code: 00884450750575 Lot Numbers: H2663133 H2729165 H2782382 Catalog Number: K09-01514U UDI-DI code:00884450392539 Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 Catalog Number: K09-01734L UDI-DI code:00884450585009 Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 Catalog Number: K09-02040C UDI-DI code: 00884450298312 Lot Numbers: H2512599 H2714847 Catalog Number: K09-02683F UDI-DI code: 00884450204597 Lot Numbers: H2487396 H2529031 H2559767 H2581856 H2595394 H2606455 H2676287 H2786364 H2841958 H2855547 Catalog Number: K09-02804B UDI-DI code: 00884450283738 Lot Numbers: H2746430 H2785501 H2804202 H2842009 H2890141 Catalog Number: K09-03844F UDI-DI code: 00884450205280 Lot Numbers: H2596165 Catalog Number: K09-04088H UDI-DI code: 00884450566374 Lot Numbers: H2426195 H2471388 H2473959 H2558086 H2581900 H2595432 H2615361 Catalog Number: K09-04088J UDI-DI code: 00884450743713 Lot Numbers: H2641900 H2691924 H2714049 H2722319 H2746454 H2825041 H2837221 H2899238 H2910128 Catalog Number: K09-04863J UDI-DI code: 00884450278642 Lot Numbers: H2405452 H2425982 H2431335…
FDA’s list runs to 20,353 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 20,353 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.