GMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
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 recall involving regulatory non-compliance with device specifications. No illnesses or injuries reported. This represents a risk-of-harm situation where manufactured devices do not match FDA-cleared specifications, but actual safety incidents have not yet occurred.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 98,700 units of GMAX SYR 12ML/LL syringes. These are non-sterile, single-use medical syringes without needles intended for medical use.
The recall was initiated because the syringe sizes and configurations produced exceed what was submitted to and cleared by the FDA. The manufactured devices do not match the specifications the FDA authorized under the firm's 510(k) submission, which is the regulatory pathway for cleared medical devices.
The affected products were distributed nationwide across California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recalled lot codes are SL22070107, SL22100203, SL23080303, SL23100403, and SL23120406.
If you have received or are using these syringes, stop use immediately. Contact the manufacturer or authorized distributor for instructions on returning or replacing the product. Healthcare facilities should check their inventory to ensure they are not using any of the recalled lot codes.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- regulatory-non-compliance
- device-specifications-mismatch
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: SL22070107
- SL22100203
- SL23080303
- SL23100403
- SL23120406
Distribution
Distributed nationwide across the United States.
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