Medline non-sterile syringes recalled for unauthorized syringe sizes and configurations
Medline non-sterile syringes (Model 91833) are being recalled because the manufactured syringe sizes and configurations do not match the company's regulatory clearance. Consumers should stop using the recalled lot numbers.
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 with no reported illnesses, injuries, or deaths. The hazard is regulatory non-compliance—the manufactured device sizes and configurations fall outside the scope of the firm's 510(k) clearance—rather than an explicitly identified safety defect or contamination. This falls within the Moderate category for regulatory and compliance issues.
Plain-English summary
Medline non-sterile syringes without needles (Model 91833, 10mL capacity) are being recalled. The recalled product is manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recall affects 346,500 units distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The syringes are being recalled because the specific sizes and configurations of syringes manufactured do not fall within the range of devices cleared by the FDA under the company's 510(k) application. This means the company did not have proper regulatory authorization for the specific syringe designs that were produced and distributed.
Consumers and healthcare facilities should stop using syringes from the affected lot codes: 63720120007, 63721070001, 63721080001, 63721090001, 63721110001, 63722030001, 63722040002, 63722050001, 63722060001, 63722090002, 63722120002, 63723020001, 63723030001, 63723050001, and 63723070001. The products should not be used and should be disposed of according to applicable medical waste disposal guidelines.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- 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 (15)
- Lot Code: LOT: 63720120007
- 63721070001
- 63721080001
- 63721090001
- 63721110001
- 63722030001
- 63722040002
- 63722050001
- 63722060001
- 63722090002
- 63722120002
- 63723020001
- 63723030001
- 63723050001
- 63723070001
Distribution
Distributed nationwide across the United States.
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