Medline Non-Sterile Syringes Recalled for Out-of-Range Sizes and Configurations
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
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 regulatory compliance recall. The manufacturer distributed devices with sizes and configurations not included in the FDA-cleared 510(k) specifications. No illnesses, injuries, or direct safety hazards have been reported. This meets the criteria for Moderate severity as a precautionary regulatory correction.
Plain-English summary
MEDLINE non-sterile syringes (Model 91841) are being recalled because the piston syringe sizes and configurations manufactured are outside the range of devices cleared under the manufacturer's FDA 510(k) application. These configurations were not included in the approved specifications and should not have been distributed.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipments were made to ports in Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Users of these syringes should identify any units that have configurations outside the originally cleared range and cease use. Contact Jiangsu Shenli Medical Production Co., Ltd. for instructions on handling the recalled devices.
No illnesses or injuries have been reported related to this recall to date.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- exceeds-510k-clearance-scope
- non-cleared-device-variant
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: N/A
Distribution
Distributed nationwide across the United States.
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