MEDLINE 5ML Non-Sterile Syringes Recalled for Unapproved Configurations
MEDLINE non-sterile syringes (Model 91859) are being recalled because their sizes and configurations exceed the scope of the manufacturer's FDA 510(k) clearance. No illnesses or injuries have been reported.
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 with no reported illnesses or injuries. The device is recalled for regulatory non-compliance—piston syringe sizes and configurations exceed the firm's 510(k) clearance scope—rather than for an explicitly identified safety defect. Per the rubric, no reported illness with a theoretical hazard warrants Moderate severity.
Plain-English summary
MEDLINE is recalling non-sterile syringes without needles for single use, branded as SYR 5ML L/L PURPLE NITRO (Model 91859). The devices are manufactured by Jiangsu Shenli Medical Production Co., Ltd.
The syringes are being recalled because their piston syringe sizes and configurations fall outside the range of devices cleared under the firm's 510(k) regulatory submission to the FDA.
The affected syringes were distributed in the United States, including in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Products were shipped through multiple ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
No illnesses or injuries have been reported in association with this recall. Healthcare facilities and individuals who have obtained these syringes should discontinue use and contact their supplier or the manufacturer for instructions regarding return or disposal.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 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
- unapproved-device-configuration
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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