GMAX Syringes Recalled for Manufacturing Outside FDA-Cleared Specifications
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, injuries, or deaths. The recall is based on regulatory non-compliance—devices manufactured outside FDA-approved specifications—without reported adverse events.
Plain-English summary
GMAX SYR 6ML/LL non-sterile syringes (Model TS2206L-M) manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. A total of 37,200 units are affected.
The syringes were manufactured in sizes and configurations that exceed the range cleared by the FDA under the company's 510(k) authorization. This regulatory non-compliance means the devices do not meet the FDA-approved specifications for this product.
The recalled lots are: SL22070104, SL22100203, SL23080303, SL23100403, and SL23120403. The units were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Users of these syringes should verify their lot numbers against the recalled list. If your supply contains a recalled lot, contact your supplier or Jiangsu Shenli Medical Production for product removal or replacement.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- Affected units
- 37,200
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 (5)
- Lot Code: LOT: SL22070104
- SL22100203
- SL23080303
- SL23100403
- SL23120403
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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