Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2557-2024

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-2557-2024`
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	2,388 kits
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`00884450363102`
Lot numbers	`T2581281`, `T2594451`, `T2606225`, `T2609782`, `T2628321`, `T2643945`, `T2685079`, `T2712303`, `T2745782`, `T2758208`, `T2800973`, `T2805964`, `T2846532`, `T2846539`, `T2850757`, `T2901641`

Product

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.

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-2557-2024. 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.