FDA Medical Device Recalls (openFDA)
Jiangsu Shenli Medical Production Co., Ltd.: Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Recall number
- Z-2112-2024
- Recalling firm
- Jiangsu Shenli Medical Production Co., Ltd.
- Product
- Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Status
- Open, Classified
- Initiated
- 2024-04-05
- Posted
- 2024-05-20
- Terminated
- not on file
- Reason
- Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- Root cause
- No Marketing Application
- Action
- 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
- Quantity
- 98700
- 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.
- Lot, serial or model codes
- Lot Code: LOT: SL22070107,SL22100203,SL23080303,SL23100403,SL23120406
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3003902757
- Firm city
- Changzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28