MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in 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 classified this as a Class II recall due to regulatory non-compliance (device specifications outside cleared range). No illnesses or injuries have been reported, which per the rubric limits this to at most High severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE non-sterile syringes without needles (Model 91827) because piston syringe sizes and configurations are outside the range of devices cleared under the firm's FDA 510(k) submission. The affected lot codes are 63721070001, 63722030001, 63722050001, 63722120002, and 63723070001.
The recalled product comprises 44,800 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Individuals who have received these syringes should cease use and contact the manufacturer or their healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- clearance-violation
- specification-non-compliance
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 (5)
- Lot Code: LOT: 63721070001
- 63722030001
- 63722050001
- 63722120002
- 63723070001
Distribution
Distributed nationwide across the United States.
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