Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co
Medical device recall Z-2576-2024. 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
- 317115 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: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
317115 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: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T2762926 T2824322 T2704382 T2863414 T2801600 T2382101 T2385423 T2407226 T2433246 T2717925 T2847798 T2433245 T2434587 T2438449…
Every code shown here, 1,998 characters
Catalog Number/UDI-DI code/Lot Numbers: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T2762926 T2824322 T2704382 T2863414 T2801600 T2382101 T2385423 T2407226 T2433246 T2717925 T2847798 T2433245 T2434587 T2438449 T2805260 T2587798 T2464348 T2479913 T2884261 T2498906 T2526998 T2530735 T2655953 T2931511 T2597132 T2565099 T2626508 T2657109 T2644387 SPPT-5F-10/D 00884450038673 T2351182 T2351183 T2367928 T2379511 T2379512 T2385424 T2398514 T2489934 T2498907 T2514802 T2753259 T2801601 T2730270 T2884264 T2879873 T2687139 T2779057 T2710244 T2861406 T2730271 T2823733 T2847801 T2704399 T2863441 T2662329 T2379513 T2424134 T2433247 T2464349 T2713162 T2805262 T2832456 T2805261 T2762927 T2433248 T2434588 T2438450 T2587799 T2472514 T2477549 T2900575 T2479284 T2622995S T2520450 T2520451 T2529637 T2626510 T2543014 T2583979 T2560921 T2610008 T2550617 T2655948 T2597133 T2587800 T2611991 T2657110 T2644390 SPPT-5F-10L/B 00884450038680 T2351188 T2365762 T2379520 T2388791 T2388793 T2680782 T2385425 T2713163 T2805263 T2779058 T2687141 T2863432 T2762928 T2823734 T2715257 T2867194 T2738091 T2852110 T2407228 T2422529 T2433254 T2489936 T2847803 T2779059 T2805264 T2433253 T2434589 T2448645 T2472525 T2479286 T2900576 T2900577 T2876381 T2885492 T2519031 T2519032 T2530734 T2626511 T2926546 T2550618 T2581125 T2587801 T2610010 T2916397 T2570319 T2657113 T2597134 T2612001 T2644391 T2655944 SPPT-5F-10S 00884450038697 T2351191 T2379524 T2385426 T2385427 T2581126 T2779063 T2871508 T2863417 T2762929 T2730272 T2814937 T2704392 T2407229 T2431282 T2503414 T2801602 T2847809 T2597135 T2626512 T2433255 T2448646 T2587802 T2472533 T2498909 T2655943 T2662331 T2464351 T2471637 T2943986 T2900578 T2543040 T2530736 T2612004 SPPT-5F-12PL 00884450277522 T2319777 T2368460 T2379527 T2438156 T2666491 SPPT-5F-17PL 00884450277546 T2385066 T2438155 T2662274 T2449563 SPPT-5F-7/D 00884450038703 T2351200 T2365767 T2384431 T2385430 T2762930 T2753262 T2704381 T2730273 T2379529 T2407234 T2422515 T2433256…
FDA’s list runs to 6,041 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 6,041 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.