Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog… — Class II medical device recall Z-2117-2024
Ongoing recall by Jiangsu Shenli Medical Production Co., Ltd., reported 2024-05-29, distributed nationwide. Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
| Recall number | Z-2117-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jiangsu Shenli Medical Production Co., Ltd., Changzhou, China |
| Recall initiated | 2024-04-05 |
| Classified | 2024-06-10 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 360,500 |
| Lot numbers | 110304, SL21, SL21030105, SL21040104, SL21070104, SL21090105, SL21110104, SL21120104, SL22030105, SL22070106, SL22100205, SL221202, SL23020204, SL23080305, SL23100405, SL23120405 |
| Model numbers | TS2210S-M |
Product
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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-2117-2024. 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.