GMAX SYR 60ML/LS Syringes Recalled for Non-Approved Specifications
Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—the devices exceed cleared specifications—which constitutes a voluntary precautionary recall rather than a known safety issue.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M), non-sterile syringes without needles for single use. Approximately 15,200 units were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The recall was issued because the piston syringe sizes and configurations are outside the range of devices cleared by the FDA under the manufacturer's 510(k) clearance. This means the syringes were marketed with specifications that were not validated or approved by FDA.
Customers who have purchased these syringes should stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. for instructions on return or disposal. Healthcare facilities should verify whether they have received any of the affected lot codes: SL21030109, SL21070111, SL21090111, SL21110111, SL21120110, SL22030111, SL22080107, SL22100213, SL23080312, or SL23100411.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Affected units
- 15,200
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 (10)
- Lot Code: LOT: SL21030109
- SL21070111
- SL21090111
- SL21110111
- SL21120110
- SL22 030111
- SL22080107
- SL22100213
- SL23080312
- SL23100411
Distribution
Part of a larger recall action
This product is one of 87 recalled by Jiangsu Shenli Medical Production Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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