Medline 20ML Non-Sterile Syringes Recalled for Non-Approved Configurations
Jiangsu Shenli Medical is recalling Medline 20ML non-sterile syringes (Model 91863) because certain piston syringe sizes and configurations were not cleared under the firm's FDA 510(k). The affected units were 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: This is an FDA Class II recall for regulatory non-compliance. The recalled syringes are outside the approved specifications under the firm's 510(k) clearance, but no illnesses, injuries, or deaths have been reported.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand SYR 20ML L/L YELLOW LIDO non-sterile syringes without needles (Model 91863). The affected lot codes are 63722050001, 63723010001, 63723020001, 63723050001, and 63723110001, totaling 4,800 units.
The recall is due to a regulatory compliance issue: piston syringes of certain sizes and configurations in these units fall outside the range of devices cleared under the firm's FDA 510(k) submission. These specific configurations were not part of the FDA review and approval process.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through distribution centers in Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Individuals and healthcare facilities in possession of these syringes should not use them and should contact Jiangsu Shenli Medical Production Co., Ltd. or their supplier regarding return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- regulatory-non-compliance
- non-cleared-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 (5)
- Lot Code: LOT: 63722050001
- 63723010001
- 63723020001
- 63723050 001
- 63723110001
Distribution
Distributed nationwide across the United States.
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