MEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance
MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.
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 for regulatory non-compliance—the syringes' configurations fall outside the FDA 510(k)-approved scope. The issue is regulatory rather than a manufacturing defect, and no illnesses or injuries are reported in the source.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE SYR 20ML/L PURPLE non-sterile syringes without needles (Model 91843), intended for single-use non-sterile applications.
The recall is due to the piston syringes' sizes and configurations being outside the range of devices cleared under the firm's FDA 510(k) premarket notification. This means the specific product variants do not have FDA authorization within their approved scope.
The recalled syringes were distributed nationwide in the United States, with distribution occurring in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipping destinations included major ports and logistics centers at Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 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
- 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: N/A
Distribution
Distributed nationwide across the United States.
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