3 mL Luer Lock Syringe (Wolf Medical) – Configuration Mismatch (2024)
Syringes manufactured without proper clearance may not meet regulatory requirements.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Component: No
Brand
Jiangsu Shenli Medical Production Co., Ltd. No.
Lot Codes / Batch Numbers
Lot Code: LOT: 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, 20231006
Products Sold
Lot Code: LOT: 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, 20231006
Jiangsu Shenli Medical Production Co., Ltd. No. is recalling Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Ca due to Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Recommended Action
Per FDA guidance
On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email shenli@syringechina.com or telephone number 0086-519-88731071
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026