GMAX 60ML Non-Sterile Syringes Recalled for Design Non-Compliance
Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes were distributed nationwide.
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: This is a Class II recall without reported hospitalizations, injuries, or illnesses. The issue is regulatory non-compliance—the manufactured devices exceed the scope of the firm's FDA 510(k) clearance—rather than an identified safety hazard. Class II recalls without reported harm are classified as Moderate.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 1,590,000 GMAX SYR 60ML/LL non-sterile syringes (Model TS2260L-M). The piston syringe sizes and configurations manufactured exceed the range of devices cleared by the FDA under the firm's 510(k) submission.
The recalled syringes were distributed nationwide across California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are: SL21030108, SL21040109, SL21070110, SL21090110, SL21110110, SL21110204, SL21110307, SL21120109, SL22030110, SL22070112, SL22080106, SL22100212, SL22120207, SL23020208, SL23040208, SL23060305, SL23080311, SL23100410, SL23100304, and SL23120410.
The FDA has classified this as a Class II recall. Additional information about this recall is available using recall number Z-2116-2024.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Affected units
- 1,590,000
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 (20)
- Lot Code: LOT: SL21030108
- SL21040109
- SL21070110
- SL21090110
- SL21110110
- SL21 110204
- SL21110307
- SL21120109
- SL22030110
- SL22070112
- SL220801 06
- SL22100212
- SL22120207
- SL23020208
- SL23040208
- SL23060305
- S L23080311
- SL23100410
- SL23100304
- SL23120410
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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