Medline Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
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: This is an FDA Class II recall where medical devices exceed the scope of approved clearance, representing risk-of-harm products where no injury has been reported. The devices were not properly validated through the FDA's 510(k) process.
Plain-English summary
Medline is recalling MEDLINE brand non-sterile syringes, Model 83081 (SYR 10ML L/S), manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recall affects approximately 2,097,200 units distributed across California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The FDA issued this Class II recall because the piston syringe sizes and configurations in the distributed product exceed the range of devices cleared under the firm's 510(k) submission. This means the actual product distributed was outside the scope of the FDA's prior authorization for this specific device type.
The recall was issued under FDA recall number Z-2046-2024. Affected lot codes are identified in the official FDA recall notice.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- improper-clearance
- unvalidated-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 (20)
- Lot Code: LOT: 63721010001
- 63721050002
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722020002
- 63722030001
- 63722040004
- 63722040006
- 63722050001
- 63722060001
- 63722070005
- 63722080002
- 63722090002
- 63722100003
Distribution
Distributed nationwide across the United States.
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