GMAX Blue Syringes Recalled for Out-of-Range Design Configurations
Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.
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 involving a regulatory non-compliance issue where the device's sizes and configurations fall outside the cleared specifications. No illnesses or injuries have been reported, placing it in the Moderate category.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. recalled 9,800 units of the GMAX SYR 10ML/LL blue syringe (model TS2210B-M) because the product's sizes and configurations exceed the range of devices cleared by the FDA under the firm's 510(k) application. These are non-sterile syringes intended for single use without needles.
The recalled lot codes are SL23040204 and SL23020211. Distribution was nationwide across California, Florida, Georgia, Illinois, Tennessee, and Virginia. The syringes were shipped through major U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities in affected states should stop using these syringes and contact the manufacturer for instructions on return or disposal. The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-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
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 (2)
- Lot Code: LOT: SL23040204
- SL23020211
Distribution
Distributed nationwide across the United States.
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