Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
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: FDA Class II recall of syringes manufactured outside the manufacturer's FDA 510(k) clearance scope, representing a risk-of-harm situation. No illnesses or injuries have been reported.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling non-sterile syringes (3mL capacity, Model 91840) sold under the MEDLINE brand name. These single-use syringes without needles were distributed in the United States.
The recalled syringes were manufactured in configurations and sizes that exceed the scope of Jiangsu Shenli's FDA 510(k) clearance. This means the products do not conform to FDA-approved specifications and may not meet established safety and quality standards.
The syringes were distributed nationwide, with documented presence in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipments were delivered to destinations including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Customers and healthcare providers who have received these syringes should immediately stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. for return or replacement instructions. All inventory of the recalled product should be identified and removed from service.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 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 (1)
- Lot Code: LOT: N/A
Distribution
Distributed nationwide across the United States.
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