GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical devices exceeding their 510(k)-cleared specifications represent a risk-of-harm because the devices have not been validated for those configurations. Although no illnesses or injuries have been reported, the regulatory non-compliance indicates unvalidated product specifications.
Plain-English summary
GMAX SYR 30ML/LL non-sterile syringes without needles, manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. The recall involves 1,117,500 units distributed across the United States, including shipments to California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The FDA issued the recall because the syringes' sizes and configurations exceed the range of devices tested and cleared under the manufacturer's 510(k) premarket notification. Medical devices that exceed their approved specifications have not been validated for those configurations.
The recalled syringes span multiple production lot codes from 2021 through 2023, including SL21030107, SL21040107, SL21070107, and others as listed in the FDA recall notice. These products were distributed through affected states following typical supply chain channels.
Customers and healthcare facilities should verify whether they have syringes from the recalled lot codes and consult the recall notice for further guidance.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-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
- improper-clearance
- 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 (17)
- Lot Code: LOT: SL21030107
- SL21040107
- SL21070107
- SL21090108
- SL21110107
- SL21 110203
- SL21110305
- SL21120107
- SL22030108
- SL22080105
- SL221002 09
- SL22120206
- SL23020207
- SL23040207
- SL23080309
- SL23100409
- SL23120408
Distribution
Distributed nationwide across the United States.
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