Use cautionMedical device recall · FDA · Published June 11, 2024
Merit Medical convenience kits with faulty syringes may pose health risks
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes with leaks and breakage risks. Affected kits include specific model numbers and lot codes from March 2024. Consumers should check their kits for these identifiers.
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.
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Contact the company
📍Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416
✎ GovInfoNow plain-language explainer
Merit Medical is recalling convenience kits that contain syringes made by Jiangsu Shenli Medical. These syringes have been identified by the FDA as having leaks and breakage issues that could harm patients. The recall is due to potential health risks from these defects. Read more at govinfonow.com/recall/54882-merit-medical-convenience-kits-with-faulty-syringes-may-pose-health.
“Merit Medical convenience kits with faulty syringes may pose health risks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54882-merit-medical-convenience-kits-with-faulty-syringes-may-pose-health. Based on FDA recall #Z-2557-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2557-2024%22&limit=1).
Merit Medical Systems, Inc. is recalling various Merit Medical convenience kits containing recalled Jiangsu Shenli Medical Production Co. Ltd. syringes, according to the FDA. The agency announced the voluntary Class II recall on June 11, 2024.
How to tell if you have it
Brand: Merit Medical
Product: Rapid Response Waste Management System Kit
Catalog Number / UDI-DI: BRC-BAL-INT-SL/B 00884450363102
The medical convenience kits contain plastic syringes affected by an 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.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since February 24, 2006. Recent brand recalls include an August 10, 2026 Embosphere Syringe Recall for packaging holes and a May 8, 2026 Splashwire Hydrophilic Guide Wire Recall for unsealed pouches. Other recent recalls of similar products include a July 10, 2026 Medline Convenience Kits Recall for contaminated components and a February 27, 2026 Medline Convenience Kits with Unapproved Syringes Safety Recall.
How to tell if you have this one
Check for the model number BRC-BAL-INT-SL/B and lot codes like 00884450363102 with specific serial numbers such as T2581281. The kits were sold starting in March 2024.
Brand
Merit Medical
Category
Medical device
FDA recall event · 23 products
All 23 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-2557-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.; Catalog Number / UDI-DI / Lot Numbers: BRC-BAL-INT-SL/B 00884450363102 T2581281 BRC-BAL-INT-SL/B 00884450363102 T2594451 BRC-BAL-INT-SL/B 00884450363102 T2606225 BRC-BAL-INT-SL/B 00884450363102 T2609782 BRC-BAL-INT-SL/B 00884450363102 T2628321 BRC-BAL-INT-SL/B 00884450363102 T2643945 BRC-BAL-INT-SL/B 00884450363102 T2685079 BRC-BAL-INT-SL/B 00884450363102 T2712303 BRC-BAL-INT-SL/B 00884450363102 T2745782 BRC-BAL-INT-SL/B 00884450363102 T2758208 BRC-BAL-INT-SL/B 00884450363102 T2800973 BRC-BAL-INT-SL/B 00884450363102 T2805964 BRC-BAL-INT-SL/B 00884450363102 T2846532 BRC-BAL-INT-SL/B 00884450363102 T2846539 BRC-BAL-INT-SL/B 00884450363102 T2850757 BRC-BAL-INT-SL/B 00884450363102 T2901641
2388 kits
Z-2558-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.; Catalog Number/UDI-DI code/Lot Numbers: K12T-10773 00884450426388 T2800379 T2824129 T2849013 T2857243 K12T-09284D 00884450602102 T2209872 T2220946 T2359067 T2364198 T2508160 T2674429 T2794927 T2800155 K12T-10621 00884450409435 T2308653 T2344516 T2411888 T2428905 T2429939 T2448507 T2452908 T2473123 T2498967 T2531706 T2597113 T2611405 T2629759 T2653268 T2685014 T2691082 T2715028 T2744136 T2776727 T2846077 T2873111 K12T-10800 00884450421093 T2280633 T2407018 T2503204 T2643484 T2680463 T2705035 T2885158 K12T-12491 00884450820605 T2905902
11837 kits
Z-2559-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Catheter Extractor is indicated for use with tunneled, double lumen hemodialysis catheters with cuff sizes ranging from 10.8 French to 14.5 French.; Catalog Number: CET200 UDI-DI code: 00884450052587 Lot Numbers: T2651502 T2700122 T2712304 T2748973 T2758209 T2779867 T2833064 T2850758 T2903817 Catalog Number: CET300 UDI-DI code: 00884450045497 T2626011 T2662043 T2701699 T2726893 T2750399 T2758210 T2805965 T2832137 T2849258 T2886083 T2921078
3631 kits
Z-2560-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.; Catalog Number: K02-00873A UDI-DI code: 00884450156261 Lot Numbers: H2597212 H2620955 H2641148 Catalog Number: K02-01105A UDI-DI code: 00884450156124 H2486384 H2542259 H2628908 Catalog Number: K02-01481A UDI-DI code: 00884450164464 H2387157 H2418377 H2472043 H2486729 H2507912 H2517550 H2526240 H2552843 H2595093 H2628968 H2655130 H2678790 H2699921 H2712471 H2747868 H2822453 H2831126 H2846806 H2868403 H2884580 H2897149 H2916452
3,647 kits
Z-2561-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.; Catalog Number: K04-00791A UDI-DI code: 00884450148471 Lot Numbers: H2387533 H2408714 H2423858 H2447173 H2484854 H2509065 H2547204 H2557351 H2640509 H2669424 H2704230 H2770492 H2780739 H2792326 H2864128 H2869756 H2916432
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.; Catalog Number/UDI-DI code/Lot Numbers: K11-00382C 00884450158425 H2379628 H2531736 H2536619 H2813488 H2881603 H2916468
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.; Catalog Number/UDI-DI code/Lot Numbers: RTT14038MB/A 00884450680100 T2882458 T2775532 T2692992 T2745797 T2823440 T2758669 T2882467 T2855297 T2692990 T2864420 T2762237 T2701080 T2748465 T2872143 T2853478 T2865442 T2560919 T2607047 T2617261 T2933737 T2657108 T2886240
7442 kits
Z-2571-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.; Catalog Number/UDI-DI code/Lot Numbers: FCL-068-00/A 00884450484326 I2902415 I2828530 FCL-069-02/A 00884450484340 I2828531 I2838807 I2851067 I2853918 I2868010 FCL-069-03/A 00884450484357 I2853921
900 kits
Z-2572-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.; Catalog Number/UDI-DI code/Lot Numbers: PLP-2505/A 00884450510308 I2889564 PLP-2514/A 00884450510551 I2902220 PLP-2516/A 00884450510575 I2894297
30 kits
Z-2573-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.; Catalog Number/UDI-DI code/Lot Numbers: OPT0242-00 00884450400586 T2167632 T2651487 T2327975 T2528428 T2845197 S1279-01 00884450050804 T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S2953 00884450050842 T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S2960 00884450389058 T2542575 T2637160 T2872115 S6002 0088445005239 T2208823
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.; Catalog Number/UDI-DI code/Lot Numbers: PLSH-1006/A 00884450495049 I2868424 PLSH-1007/A 00884450495056 I2889342 I2903951 PLSH-1008/A 00884450495087 I2873505 PLSH-1009.5/A 00884450495568 I2873507 PLSH-2506/A 00884450495490 I2872319 I2914441 PLSH-2507/A 00884450495506 I2868427 I2889346
Look for the model number BRC-BAL-INT-SL/B and lot codes like 00884450363102 with serial numbers such as T2581281.
Contact Merit Medical
Reach out to Merit Medical for assistance with the recall process or to get replacement kits.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2557-2024 (June 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2557-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.