Non-sterile syringes recalled for manufacturing outside FDA-cleared specifications
Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.
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: FDA Class II recall with no reported illnesses, injuries, or adverse events. The hazard is regulatory non-compliance—manufacturing outside cleared specifications—without reported patient harm, consistent with a precautionary recall.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE brand non-sterile syringes without needles (Model 83087, product name SYR 20ML L/S) due to manufacturing non-compliance with FDA-cleared specifications.
The recalled syringes were manufactured in piston configurations and sizes that fall outside the range of devices covered under the firm's 510(k) clearance. This represents a deviation from the specifications approved by the FDA.
The recall involves 619,200 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Affected products were distributed through multiple U.S. distribution channels including ports and customer-designated warehouses.
No adverse events, illnesses, or injuries related to this recall have been reported to the FDA. Consumers and healthcare facilities that received affected units should verify their product lot numbers against the recall list.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- regulatory-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 (20)
- Lot Code: LOT: 63721010002
- 63721010004
- 63721020002
- 63721040002
- 63721050002
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722030001
- 63722040004
- 63722050001
- 63722060001
- 63722070005
- 63722080002
- 63722100003
Distribution
Distributed nationwide across the United States.
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