FDA Recalls GMAX Non-Sterile 10ML Syringes Due to Non-Compliant Manufacturing Specifications
GMAX non-sterile syringes are being recalled because their actual sizes and configurations exceed the range of specifications the manufacturer obtained FDA clearance for.
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 classified this as a Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is regulatory non-compliance—syringes manufactured outside FDA-cleared specifications—rather than a documented safety threat.
Plain-English summary
FDA is recalling GMAX SYR 10ML non-sterile syringes manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recalled product is a non-sterile syringe without needles intended for single use, Model TS2210L-M. Approximately 5,829,600 units were distributed to the United States.
The recall was initiated because the syringes' actual sizes and configurations exceed the range of devices that the manufacturer obtained clearance for through the FDA's 510(k) premarket notification process. This means the distributed products do not match the specifications approved by the FDA.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Multiple lot codes were included in the recall, ranging from SL21030104 to SL23120404.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-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
- specification-mismatch
- 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 (20)
- Lot Code: LOT: SL21030104
- SL21040103
- SL21070103
- SL21090104
- SL21110103
- SL21 110201
- SL21110303
- SL21120103
- SL22030104
- SL22070105
- SL220801 02
- SL22100204
- SL22120202
- SL23020203
- SL23040203
- SL23060303
- S L23080304
- SL23100404
- SL23100303
- SL23120404
Distribution
Distributed nationwide across the United States.
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