Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2577-2024
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-2577-2024 |
|---|---|
| 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 | 4,027 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450484319, 00884450484418, 00884450484456, 00884450484463, 00884450484487 |
| Lot numbers | FCL-083-02/A, I2786685, I2786687, I2803269, I2808954, I2808956, I2818469, I2818470, I2818471, I2818472, I2828532, I2828533, I2828534, I2838811, I2838814, I2851068, I2851069, I2851070, I2853922, I2853923, I2853925, I2868006, I2868008, I2868009, I2868011, I2879275, I2879276, I2889546, I2889548, I2889549, I2893943, I2901154, I2901183, I2902412, I2902413, I2902414, I2912319, I2912321, I2931689, I2931690 and 5 more |
| Model numbers | FCL-083-02/A, WOR-CSG-B1-09/A, WOR-CSG-B2-09/A, WOR-CSG-BL1-09/A, WOR-CSG-E-90/A |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
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-2577-2024. 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.