Medline 10ml Syringes Recalled for Exceeding FDA Clearance Range
Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.
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 or injuries. The hazard is regulatory non-compliance with the 510(k) clearance scope rather than a specific identified safety defect.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 39,200 Medline non-sterile syringes without needles (Model 91850, 10ml). The recalled syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through major U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The recall was initiated because the piston syringe sizes and configurations are outside the range of devices cleared under the manufacturer's FDA 510(k) submission. The affected lot codes are: 63721040002, 63721120001, 63722010001, 63722080002, 63722100003, 63723100003, and 63723110001.
No injuries or illnesses associated with these syringes have been reported. Customers who have received these products should stop using them and contact their distributor or Jiangsu Shenli Medical for instructions on replacement or return.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- 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 (7)
- Lot Code: LOT: 63721040002
- 63721120001
- 63722010001
- 63722080 002
- 63722100003
- 63723100003
- 63723110001
Distribution
Distributed nationwide across the United States.
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