FDA Recalls Medline Syringes Manufactured Outside Approved Specifications
Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.
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 a Class II FDA recall where no hospitalization, injury, or death is reported. Per the rubric, Class II recalls without reported harm and where the hazard is regulatory non-compliance rather than an inherent product defect qualify for Moderate severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 9,800 Medline SYR 5ML L/L RED NITRO non-sterile syringes without needles (Model/Catalog Number 91866, Lot Code 63722070002). The devices were manufactured in piston syringe sizes and configurations that fall outside the range of devices cleared under the firm's 510(k) submission to the FDA.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments arriving through ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Patients and healthcare facilities that have received these devices should immediately stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. or their supplier for instructions on return or disposal.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- 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: 63722070002
Distribution
Distributed nationwide across the United States.
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