Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
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: The recall involves FDA Class II medical devices with actual specifications that deviate from FDA-cleared designs, representing a risk-of-harm scenario. No illnesses or injuries have been reported, placing this under the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.
Plain-English summary
Medline 3-milliliter non-sterile syringes (model 91821) manufactured by Jiangsu Shenli Medical Production Co., Ltd. have been recalled. The product is intended for single-use injection without needles. A total of 20,000 units were distributed.
The syringes are being recalled because their actual sizes and configurations fall outside the range of devices that were approved under the firm's FDA 510(k) clearance. This means the devices as manufactured do not match the specifications that were tested and approved by the FDA.
The affected syringes were distributed nationwide to healthcare providers and distributors in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot is identified as LOT:63721110001.
Healthcare facilities and consumers who have received these syringes should discontinue use and return them to their supplier or the manufacturer. The recalling firm is Jiangsu Shenli Medical Production Co., Ltd.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- specification-mismatch
- 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 (1)
- Lot Code: LOT:63721110001
Distribution
Distributed nationwide across the United States.
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