FDA Recalls GMAX Syringes Due to Unapproved Configuration
Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—device configurations outside the scope of cleared specifications—without demonstrated safety impact, warranting a Moderate classification.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling GMAX SYR 12ML/LS syringes (Model TS2212S-M) due to regulatory non-compliance. The recalled syringes were manufactured in sizes and configurations that fall outside the scope of the firm's FDA 510(k) clearance.
Approximately 303,800 units were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are SL22120209, SL23080314, and SL23100201.
Healthcare facilities and consumers in possession of these syringes should contact Jiangsu Shenli Medical Production Co., Ltd. for further instructions regarding this recall.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- unapproved-configuration
- regulatory-non-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: LOT: SL22120209
- SL23080314
- SL23100201
Distribution
Distributed nationwide across the United States.
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