GMAX SYR 35ML Non-Sterile Syringes Recalled for Regulatory Non-Compliance
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
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 or injuries. The hazard is regulatory non-compliance (device specifications exceed approved range) rather than a demonstrated safety risk.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 7,750 GMAX SYR 35ML/LL non-sterile syringes (Model TS2235L-M). The syringes are being recalled because the piston syringe sizes and configurations are outside the range of devices that received FDA clearance under the firm's 510(k) submission.
The affected products were distributed across the United States, including California, Florida, Georgia, Illinois, Tennessee, and Virginia. Affected lot numbers are SL22070111, SL22100211, and SL23080310.
At this time, no illnesses or injuries have been reported. Consumers who possess these syringes should discontinue use and contact the manufacturer or the FDA for further instructions. Healthcare providers and patients should not use these syringes.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 7,750
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 (3)
- Lot Code: LOT: SL22070111
- SL22100211
- SL23080310
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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