Brand Name: MEDIGRATIVE recallZ-2100-2024 · Jiangsu Shenli Medical Production Co., Ltd. · initiated Apr 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Jiangsu Shenli Medical Production Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
FDA root cause category: No Marketing Application
What the company is doing
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 [email protected] or telephone number 0086-519-88731071
Recall details
- Recall number
- Z-2100-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 5, 2024
- Posted by the FDA
- May 20, 2024
- Recalling firm
- Jiangsu Shenli Medical Production Co., Ltd.
- Quantity
- 110000
- Product code
- FMF
- 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.
Product description
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
Code information (models, lots, serial numbers)
UDI-DI code: 00853620005241 Lot Code: LOT: EJ117-5, EJ117-6, EJ117-7, EJ117-8, EJ117-9, EJ117-10, EJ117-11
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 100cc Syringe 044643686500Merit Pharmaceutical · Syringe, Piston1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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