Class II — Jiangsu Shenli Medical Production Co., Ltd.
| Recalling firm | Jiangsu Shenli Medical Production Co., Ltd |
|---|---|
| Registered facility | JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). |
| Product | Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No |
| Quantity | 44800 |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk. |
| Initiated | 2024-04-05 |
| Classified | 2024-06-10 |
| Recall number | Z-2059-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Jiangsu Shenli Medical Production Co., Ltd. (Z-2059-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94520/
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