MEDLINE Non-Sterile Syringes Recalled for Configuration Exceeding FDA Clearance
Jiangsu Shenli Medical Production is recalling MEDLINE non-sterile syringes because certain configurations exceed the scope approved by the FDA. The recalled syringes were distributed nationwide across multiple states.
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 recall with no reported illnesses or injuries. The issue is regulatory non-compliance: device configurations exceed the scope of the firm's FDA-approved 510(k) clearance, rather than a documented safety defect.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE non-sterile syringes (Model 83079, SYR 60mL L/S) for use as single-use medical devices. Approximately 139,100 units have been recalled. These syringes were distributed nationwide, with shipments to California, Florida, Georgia, Illinois, Tennessee, and Virginia through major U.S. ports and distribution centers.
The recall was initiated because the syringe sizes and configurations exceed the range of devices cleared under the firm's 510(k) premarket notification. This means the syringes as manufactured do not match the specifications approved by the FDA before they were distributed.
Healthcare facilities and medical product distributors who have received these syringes should cease use immediately. Contact Jiangsu Shenli Medical Production for return and replacement instructions. The recalled lot codes are: 63721010004, 63721020002, 63721050002, 63721060001, 63721070004, 63721070006, 63721080001, 63721090001, 63721110001, 63721120001, 63722010001, 63722030001, 63722040001, 63722040006, 63722050001, 63722070002, 63722080002, 63722100003, 63722120002, 63723010001, 63723030001, 63723050001, 63723060001, 63723070001, 63723080001, 63723090002, 63723100003, 63723110001, and 63723120002.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringe
- Hazard
- regulatory-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 (20)
- Lot Code: LOT: 63721010004
- 63721020002
- 63721050002
- 63721060001
- 63721070004
- 63721070006
- 63721080001
- 63721090001
- 63721110001
- 63721120001
- 63722010001
- 63722030001
- 63722040001
- 63722040006
- 63722050001
- 63722070002
- 63722080002
- 63722100003
- 63722120002
- 63723010001
Distribution
Distributed nationwide across the United States.
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