MEDLINE syringes recalled for sizes outside FDA clearance
MEDLINE is recalling 700 non-sterile 10ML syringes because their piston sizes and configurations exceed the range approved by FDA. No illnesses have been reported. Consumers should stop using these syringes.
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 for medical device with non-compliant specifications. No illnesses or injuries have been reported, so this falls under 'risk-of-harm products where injury has not yet been reported' per the severity rubric.
Plain-English summary
MEDLINE is recalling 700 non-sterile 10ML syringes for single use (Model 91873, Lot 63723030001) manufactured by Jiangsu Shenli Medical Production Co., Ltd. These syringes are recalled because their piston sizes and configurations exceed the range of devices cleared by the FDA under the manufacturer's 510(k) application.
The affected syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments sent to major ports and warehouses including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities should immediately stop using these syringes. Contact the manufacturer or your distributor to arrange return or proper disposal of the affected units.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Hazard
- non-compliant-specifications
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: 63723030001
Distribution
Distributed nationwide across the United States.
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