MEDLINE Non-Sterile Syringes Recalled for Being Outside Cleared Specifications
Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.
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: Medical syringes are risk-of-harm products used directly in patient care. These devices fall outside FDA-cleared specifications, meaning they may not function as approved. No illnesses or injuries have been reported. This recall qualifies as a risk-of-harm product without reported injury, corresponding to Score 3 (High) severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE brand 10ml non-sterile syringes without needles (Model 91856). The recall affects 33,600 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with lot numbers 63721060001, 63722060001, and 63723030001.
The syringes are being recalled because their sizes and configurations are outside the range of devices cleared under the manufacturer's 510(k) submission to the FDA. Because the devices do not match the approved specifications, they may not function as intended.
Healthcare facilities and providers currently using these syringes should stop use immediately and contact the manufacturer for replacement or refund options.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- device-malfunction
- 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 (3)
- Lot Code: LOT: 63721060001
- 63722060001
- 63723030001
Distribution
Distributed nationwide across the United States.
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