FDA Device recall Z-2107-2024
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Descripti…
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Descripti… by Jiangsu Shenli Medical Production, citing piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-05 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Jiangsu Shenli Medical Production |
| Distribution | US |
Product
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
Reason
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Identifiers
| code_info | Lot Code: LOT: 20200204, 20200301, 20201201, 20210104, 20210301, 20211112, 20220414, 20220614, 20221015, 20231006 20240301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.