Medline Syringes Recalled: Device Configuration Outside FDA Clearance Scope
Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is regulatory non-compliance—the manufactured devices do not match the specifications cleared under the firm's 510(k) submission.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. (Medline brand) is recalling approximately 7,000 non-sterile syringes without needles, Model 91857 (Lot Code: 63722120002).
The devices are being recalled because the piston syringe sizes and configurations exceed the range of devices cleared by FDA under the company's 510(k) submission. This means the manufactured devices do not match the specifications approved by the agency.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through normal clinical distribution channels.
Consumers or healthcare facilities who have received these syringes should discontinue use and contact Jiangsu Shenli Medical or their Medline distributor for instructions on product return or destruction.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- 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: 63722120002
Distribution
Distributed nationwide across the United States.
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