MEDLINE Non-Sterile Syringes Model 91822 Recalled for Unapproved Configuration
MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 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: FDA Class II recall without reported illnesses or injuries. The hazard is regulatory non-compliance—the device configurations were not approved under the manufacturer's 510(k) clearance—with no documented adverse events.
Plain-English summary
MEDLINE non-sterile syringes, Model 91822, manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. The product is a 3-milliliter syringe without needle, intended for single use.
The FDA has classified this as a Class II recall because the syringe sizes and configurations fall outside the range of devices cleared under the manufacturer's 510(k) regulatory clearance. The product specifications do not match the FDA-approved parameters.
Approximately 12,000 units were distributed in the United States, primarily across California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot code is LOT:63722120002.
Users of this product should discontinue use and contact the manufacturer or distributor for guidance on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- unapproved-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 (1)
- Lot Code: LOT:63722120002
Distribution
Distributed nationwide across the United States.
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