Medline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications
Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.
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 or injuries. The hazard stems from regulatory non-compliance with manufacturing scope rather than a documented safety defect, consistent with precautionary manufacturing recalls.
Plain-English summary
Medline piston non-sterile syringes without needles (Model 91878) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled for 12,160 units distributed across multiple lot codes.
The syringes were manufactured in sizes and configurations that exceed the scope of devices cleared under the firm's FDA 510(k) clearance. The units do not comply with the specifications for which they were cleared for distribution in the United States.
The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Tennessee, and Virginia through major U.S. shipping ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- manufacturing-non-compliance
- out-of-specification
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 (11)
- Lot Code: LOT: 63721070004
- 63722010001
- 63722030001
- 63722050 001
- 63722080002
- 63722080004
- 63722120004
- 63723030001
- 63723050001
- 63723060005
- 63723120 002
Distribution
Distributed nationwide across the United States.
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