Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2579-2024

Ongoing recall by Merit Medical Systems, Inc., reported 2024-08-21, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L

Recall number	`Z-2579-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Merit Medical Systems, Inc., South Jordan, UT, United States
Recall initiated	2024-06-11
Classified	2024-08-12
Reported by FDA	2024-08-21
Distributed	Nationwide (US)
Quantity	1,753,625 kits
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`00008844503459`, `00884450048139`, `00884450048160`, `00884450048382`, `00884450048764`, `00884450048771`, `00884450048931`, `00884450049112`, `00884450049204`, `00884450049334`, `00884450049372`, `00884450053607`, `00884450053690`, `00884450053706`, `00884450053775`, `00884450055083`, `00884450055106`, `00884450140796`, `00884450140826`, `00884450140833`, `00884450140840`, `00884450166406`, `00884450169513`, `00884450169520`, `00884450172841` and 475 more
Lot numbers	`K05-02166B`, `K05T-00380C`, `K05T-01674B`, `K05T-01863`, `K05T-01941C`, `K05T-01955`, `K05T-02138`, `K05T-02159`, `K05T-02272G`, `K05T-02272H`, `K05T-02515A`, `K05T-02533`, `K05T-02728`, `K05T-02733C`, `K05T-03153`, `K05T-03201`, `K09T-00318D`, `K09T-07304G`, `K09T-07627L`, `K09T-07627M`, `K09T-08747`, `K09T-08774F`, `K09T-08952`, `K09T-09037J`, `K09T-09358`, `K09T-09576J`, `K09T-09760C`, `K09T-09978A`, `K09T-10485L`, `K09T-10728H`, `K09T-10728J`, `K09T-11022C`, `K09T-11022D`, `K09T-11379F`, `K09T-11430B`, `K09T-11478A`, `K09T-11738D`, `K09T-11798`, `K09T-11875B`, `K09T-12020B` and 460 more
Model numbers	`K05-02166B`, `K05T-00380C`, `K05T-01674B`, `K05T-01863`, `K05T-01920F`, `K05T-01941C`, `K05T-01955`, `K05T-02138`, `K05T-02159`, `K05T-02272G`, `K05T-02272H`, `K05T-02515A`, `K05T-02533`, `K05T-02728`, `K05T-02733C`, `K05T-03153`, `K05T-03201`, `K09T-00318D`, `K09T-07304G`, `K09T-07627L`, `K09T-07627M`, `K09T-08747`, `K09T-08774F`, `K09T-08952`, `K09T-09037J` and 303 more

Product

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T-02272H K05T-02515A K05T-02533 K05T-02728 K05T-02733C K05T-03153 K05T-03201 K09T-00318D K09T-07304G K09T-07627L K09T-07627M K09T-08747 K09T-08774F K09T-08952 K09T-09037J K09T-09358 K09T-09576J K09T-09760C K09T-09978A K09T-10485L K09T-10728H K09T-10728J K09T-11022C K09T-11022D K09T-11379F K09T-11430B K09T-11478A K09T-11738D K09T-11798 K09T-11875B K09T-12020B K09T-12020C K09T-12200 K09T-12538F K09T-12538G K09T-12883B K09T-12883C K09T-12942B K09T-12942C K09T-12942D K09T-12942F K09T-12970B K09T-13293 K09T-13293A K09T-13294 K09T-13294A K09T-13384B K09T-13384C K09T-13444B K09T-13459A K09T-13459B K09T-13681A K09T-13740 K09T-13927 K09T-13927A K09T-13949 K09T-13972 K09T-14025 K09T-14028B K09T-14035 K09T-14072 K09T-14218 K10T-01528G K10T-01528H K10T-03769F K10T-04233J K10T-04941B K10T-05595A K10T-05611B K10T-05680B K10T-06085 K10T-06085A K10T-06101 K10T-12092 K10T-12092A K12-05727F K12T-01737D K12T-01816A K12T-01996K K12T-02064 K12T-02285F K12T-02667A K12T-02703C K12T-02703F K12T-02911F K12T-02911G K12T-02940 K12T-03196 K12T-03312 K12T-03724F K12T-03933C K12T-03975A K12T-03979C K12T-04085 K12T-04270A K12T-04271B K12T-04348A K12T-04383G K12T-04707 K12T-04926G K12T-05302D K12T-05303D K12T-05303F K12T-05327D K12T-05432F K12T-05432G K12T-05627 K12T-05849C K12T-05849D K12T-05849F K12T-05850B K12T-05850C K12T-05903B K12T-05968D K12T-05974A K12T-05996M K12T-05996N K12T-06043 K12T-06313B K12T-06412A K12T-06431A K12T-06436 K12T-06694A K12T-06821 K12T-06826 K12T-06839A K12T-07986C K12T-08071C K12T-08071D K12T-08072D K12T-08072F K12T-08166D K12T-08703 K12T-08964F K12T-09013F K12T-09237A K12T-09292A K12T-09338D K12T-09456B K12T-09840B K12T-10464 K12T-10514A K12T-10515 K12T-10515A K12T-10516 K12T-10562 K12T-10583A K12T-10586A K12T-10649 K12T-10664A K12T-10881B K12T-11049 K12T-11151 K12T-11586 K12T-11626B K12T-11626C K12T-11680 K12T-11684 K12T-11826 K12T-11853P K12T-11857B K12T-11880 K12T-11880A K12T-11880B K12T-11901 K12T-11903 K12T-11910 K12T-11923 K12T-11923A K12T-11924A K12T-11925A K12T-11943B K12T-11943C K12T-11984 K12T-11985 K12T-11996 K12T-12017 K12T-12091 K12T-12138 K12T-12149 K12T-12153 K12T-12155 K12T-12155A K12T-12155B K12T-12157 K12T-12157A K12T-12157B K12T-12224 K12T-12224A K12T-12224B K12T-12230 K12T-12242 K12T-12242A K12T-12244 K12T-12285A K12T-12291 K12T-12291A K12T-12323 K12T-12331A K12T-12397 K12T-12403 K12T-12406 K12T-12406A K12T-12407 K12T-12419 K12T-12448 K12T-12448A K12T-12494 K12T-11210 K12T-12321 K20T-00002 K20T-00004A K20T-00012 K20T-00016A K20T-00019 K20T-00027 K20T-00031 K20T-00035 K12T-02045 K12T-02909 K12T-03993A K12T-06280 K12T-09329A K12T-09368A K12T-10157 K12T-12095 K05T-01920F K09T-10485M K09T-14028 K09T-14028A K10-04922C K10T-00554J K10T-00554L K10T-00861D K10T-01428A K10T-01785L K10T-02735D K10T-03122A K10T-03348K K10T-03627F K10T-03627G K10T-03627H K10T-03776F K10T-03776G K10T-03784 K10T-03810A K10T-03810B K10T-03979M K10T-04060G K10T-04113Q K10T-04113R K10T-04160R K10T-04163H K10T-04199C K10T-04200C K10T-04256H K10T-04338G K10T-04415K K10T-04463D K10T-04500B K10T-04578B K10T-04655B K10T-04718F K10T-04723B K10T-04744D K10T-04774D K10T-04775 K10T-04780 K10T-04806A K10T-04844N K10T-04861B K10T-04862 K10T-04892 K10T-04983B K10T-04986F K10T-05012G K10T-05012H K10T-05081F K10T-05082G K10T-05165A K10T-05197B K10T-05219 K10T-05272C K10T-05307B K10T-05308B K10T-05365A K10T-05366B K10T-05367 K10T-05397 K10T-05451N K10T-05451R K10T-05462 K10T-05493B K10T-05504C K10T-05518 K10T-05531 K10T-05541C K10T-05541D K10T-05592B K10T-05593C K10T-05612 K10T-05651B K10T-05655 K10T-05662 K10T-05665A K10T-05666 K10T-05666A K10T-05667F K10T-05667G K10T-05667H K10T-05670B K10T-05711A K10T-05711B K10T-05746A K10T-05747A K10T-05797 K10T-05812A K10T-05817 K10T-05819

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2579-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.