Jiangsu Shenli Medical Production Co., Ltd.: Medical Device Recall in 2024 - (Recall #: Z-2106-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No

Product Classification:

Class II

Date Initiated: April 5, 2024
Date Posted: May 29, 2024
Recall Number: Z-2106-2024
Event ID: 94520
Reason for Recall:

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Status: Ongoing
Product Quantity: 483210
Code Information:

Lot Code: LOT: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated