Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2578-2024. 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
- 168157 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: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures
168157 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-01138 00884450336007 T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A…
Every code shown here, 1,992 characters
Catalog Number/UDI-DI code/Lot Numbers: K09T-01138 00884450336007 T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A 00884450566596 T2816450 T2832465 T2854450 T2871539 T2901668 K09T-04757F 00884450388396 T2385183 T2434454 T2495466 T2525635 T2556829 T2584607 T2597014 T2640329 T2675582 T2708063 T2805969 T2843261 T2885245 T2895071 T2916416 K09T-04835H 00884450270394 T2287853 T2315252 T2349573 T2360340 T2386004 T2390911 T2414694 T2434737 T2449763 T2494448 T2587504 T2635754 T2667679 T2680871 T2712317 T2738104 T2781020 T2807074 T2833069 T2846966 T2864503 T2876387 K09T-07256D 00884450603703 T2360341 T2442955 T2498994 T2512482 T2560718 T2662053 T2745275 T2753062 T2800989 T2816846 K09T-07588B 00884450264386 T2205472 T2241180 T2314951 T2329404 T2349817 T2385184 T2386005 T2399751 T2442956 T2466089 T2479716 T2515708 T2536603 T2556831 T2560719 T2587556 T2606272 T2623834 T2657321 T2662059 T2690340 T2718870 T2748986 T2779872 T2800990 T2816851 T2846968 T2864504 T2874066 T2881132 T2906059 K09T-07611K 00884450290392 T2596860 T2652491 T2699218 T2699221 T2708069 T2717940 T2738107 T2762257 T2800991 T2833071 T2849220 T2883795 T2886087 T2939092 K09T-07649K 00884450390627 T2305612 K09T-07649L 00884450644102 T2339957 T2366225 T2386671 T2407056 T2417965 T2456584 T2495473 T2525638 T2550175 T2571768 T2594494 T2606278 T2640321 T2676814 K09T-07649M 00884450763506 T2712330 T2800995 T2805971 T2829278 T2846972 T2895076 T2913241 T2918196 K09T-09035H 00884450390634 T2305169 K09T-09035J 00884450644119 T2407057 T2417968 T2449348 T2456585 T2495474 T2525665 T2550176 T2587558 T2614918 T2640322 T2662061 T2676826 T2739363 K09T-09035M 00884450783108 T2774709 T2801082 K09T-09035N 00884450801956 T2832138 T2845195 T2850766 T2883742 T2886099 T2936006 K09T-09107K 00884450388402 T2333502 T2428903 T2457858 T2495482 T2551032 T2584608 T2643751 T2807078 K09T-09319C 00884450336328 T2333503 T2406792…
FDA’s list runs to 19,530 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 19,530 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.