Medline non-sterile syringes recalled for exceeding 510(k) clearance scope
Jiangsu Shenli Medical recalled 18,900 Medline non-sterile syringes (Model 91842) because their sizes and configurations exceed the FDA's approved scope under the firm's 510(k) clearance.
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 due to regulatory non-compliance—devices exceed the firm's 510(k) cleared scope. No injuries or illnesses have been reported; this is a precautionary measure to ensure devices match their authorized specifications.
Plain-English summary
Medline non-sterile syringes (Model 91842, 10-mL capacity, purple) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled. Approximately 18,900 units were distributed in the United States.
The recall was issued because the piston syringe sizes and configurations of the affected products fall outside the range approved by the FDA under the firm's 510(k) submission. This means the devices do not match the specifications that were authorized for marketing.
The affected products were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are: 63721080001, 63721090001, 63721100001, 63721110001, 63721120001, 63722030001, 63722050001, 63722080002, 63722100003, 63722120002, 63723020001, 63723030001, 63723050001, 63723060001, 63723070001, 63723090002, 63723100003, and 63723110001.
Customers who have received the affected syringes should not use them pending further instructions. For additional information, customers should contact their supplier or the manufacturer.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
- design-scope-violation
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 (18)
- Lot Code: LOT: 63721080001
- 63721090001
- 63721100001
- 63721110 001
- 63721120001
- 63722030001
- 63722050001
- 63722080002
- 63722100003
- 63722120002
- 63723020 001
- 63723030001
- 63723050001
- 63723060001
- 63723070001
- 63723090002
- 63723100003
- 63723110 001
Distribution
Distributed nationwide across the United States.
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