Medline Non-Sterile Syringes Recalled for Exceeding Approved Specifications
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand 10ML non-sterile syringes (Model 91874) because piston sizes and configurations exceed the range approved under the firm's FDA 510(k) clearance.
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 product is a risk-of-harm medical device—syringes operating outside FDA-cleared specifications could affect proper function or delivery accuracy. No illnesses or injuries have been reported, but the regulatory non-compliance with device configuration warrants a higher severity level per the criteria for risk-of-harm products.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand SYR 10ML L/S RED non-sterile syringes without needles (Model 91874) for single use.
The products were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. After customers place orders, the manufacturer arranges production and delivery to customer-designated ports or warehouses, primarily Shanghai, with shipment to Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The recall is due to regulatory non-compliance: the piston syringe sizes and configurations exceed the range of devices cleared under the firm's 510(k) premarket notification approval.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
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: N/A
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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