Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2565-2024

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-2565-2024`
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	138,471
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`00884450171356`, `00884450171363`, `00884450171509`, `00884450172704`, `00884450172896`, `00884450173978`, `00884450174036`, `00884450174173`, `00884450174302`, `00884450174470`, `00884450175088`, `00884450176054`, `00884450176320`, `00884450176511`, `00884450176740`, `00884450176795`, `00884450177075`, `00884450177457`, `00884450193778`, `00884450196021`, `00884450197073`, `00884450197202`, `00884450197523`, `00884450201459`, `00884450202074` and 52 more
Lot numbers	`H2351711`, `H2352552`, `H2353207`, `H2354646`, `H2354650`, `H2359761`, `H2381074`, `H2381217`, `H2382837`, `H2384157`, `H2386135`, `H2386175`, `H2391149`, `H2391156`, `H2391366`, `H2393452`, `H2397178`, `H2398057`, `H2399047`, `H2399127`, `H2401233`, `H2401236`, `H2402908`, `H2402920`, `H2402965`, `H2405971`, `H2406427`, `H2406448`, `H2406989`, `H2407705`, `H2408885`, `H2408968`, `H2408970`, `H2409371`, `H2409929`, `H2410331`, `H2412350`, `H2412351`, `H2412595`, `H2413270` and 460 more
Model numbers	`K10-00592K`, `K10-00777BP`, `K10-00785LP`, `K10-00814L`, `K10-00839FP`, `K10-01270T`, `K10-01571C`, `K10-01700AP`, `K10-01722QP`, `K10-03184`, `K10-03220AP`, `K10-03290D`, `K10-03327D`, `K10-03364A`, `K10-03383BP`, `K10-03591KP`, `K10-03666B`, `K10-04183CP`, `K10-04201GP`, `K10-04291AP`, `K10-04360B`, `K10-04386CP`, `K10-04413A`, `K10-04426B`, `K10-04429` and 52 more

Product

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

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-2565-2024. 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.