GMAX SYR 10ML Control Syringes Recalled for Exceeding Device Specifications
Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes because the device specifications exceed FDA-cleared limits. Approximately 348,800 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: This is an FDA Class II recall with no reported illnesses or injuries. The recall addresses a regulatory non-compliance issue: the piston syringe sizes and configurations exceed what was cleared under the firm's 510(k) submission. Without evidence of actual harm or specific safety hazards identified, this is classified as a precautionary regulatory recall.
Plain-English summary
Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes (Model TS3210L-M). The product is a non-sterile syringe without needles, intended for single use.
The recall was issued because the piston syringe sizes and configurations exceed the range of devices that received FDA clearance under the firm's 510(k) submission. The affected lot codes include SL21040108, SL21070109, SL21090109, SL21110109, SL21110306, SL21120108, SL22030112, SL22070113, SL22100214, SL22120208, SL23020209, SL23060306, SL23080313, SL23100412, and SL23120411.
Approximately 348,800 units have been distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through various U.S. ports including Los Angeles, Long Beach, Chicago, Miami, Savannah, Nashville, and Norfolk.
Customers with affected syringes should contact Jiangsu Shenli Medical Production for guidance regarding the recalled product. Additional information is available through the FDA's medical device recall notification system.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- 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 (15)
- Lot Code: LOT: SL21040108
- SL21070109
- SL21090109
- SL21110109
- SL21110306
- SL21 120108
- SL22030112
- SL22070113
- SL22100214
- SL22120208
- SL23020209
- SL23060306
- SL23 080313
- SL23100412
- SL23120411
Distribution
Distributed nationwide across the United States.
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