GMAX 60ML Non-Sterile Syringes Recalled for Design Non-Compliance
Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes 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: This is a Class II recall without reported hospitalizations, injuries, or illnesses. The issue is regulatory non-compliance—the manufactured devices exceed the scope of the firm's FDA 510(k) clearance—rather than an identified safety hazard. Class II recalls without reported harm are classified as Moderate.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 1,590,000 GMAX SYR 60ML/LL non-sterile syringes (Model TS2260L-M). The piston syringe sizes and configurations manufactured exceed the range of devices cleared by the FDA under the firm's 510(k) submission.
The recalled syringes were distributed nationwide across California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are: SL21030108, SL21040109, SL21070110, SL21090110, SL21110110, SL21110204, SL21110307, SL21120109, SL22030110, SL22070112, SL22080106, SL22100212, SL22120207, SL23020208, SL23040208, SL23060305, SL23080311, SL23100410, SL23100304, and SL23120410.
The FDA has classified this as a Class II recall. Additional information about this recall is available using recall number Z-2116-2024.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-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
- regulatory-non-compliance
- unauthorized-design-specifications
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: SL21030108
- SL21040109
- SL21070110
- SL21090110
- SL21110110
- SL21 110204
- SL21110307
- SL21120109
- SL22030110
- SL22070112
- SL220801 06
- SL22100212
- SL22120207
- SL23020208
- SL23040208
- SL23060305
- S L23080311
- SL23100410
- SL23100304
- SL23120410
Distribution
Distributed nationwide across the United States.
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