Medline Non-Sterile Syringes Recalled for Unapproved Configuration
Medline 10mL non-sterile syringes have been recalled because their piston size and configuration fall outside the range cleared by FDA. The recall affects 7,000 units distributed nationwide.
What this means for you
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 an FDA Class II recall for regulatory non-compliance, with syringes manufactured in sizes and configurations outside the FDA-approved range. The recall is based on manufacturing specifications rather than reported safety events.
Plain-English summary
Medline SYR 10ML L/L BLUE SALINE syringes (Model 91849), manufactured by Jiangsu Shenli Medical Production Co., Ltd., are non-sterile syringes without needles intended for single use. The recall involves approximately 7,000 units (Lot Code: 63721120001).
The syringes are being recalled because their piston sizes and configurations fall outside the range of devices that were cleared by the FDA under the manufacturer's 510(k) premarket notification.
The recalled syringes were distributed nationwide, including to California, Florida, Georgia, Illinois, Tennessee, and Virginia, through various port and distribution centers.
Persons who have received these syringes should contact the manufacturer, Jiangsu Shenli Medical Production Co., Ltd., or their healthcare supplier for further guidance.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Hazard
- manufacturing-defect
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: 63721120001
Distribution
Distributed nationwide across the United States.
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