Medline Syringes Recalled for Operating Outside FDA-Cleared Configurations
Jiangsu Shenli Medical is recalling 12,600 non-sterile syringes (Model 91855) distributed nationwide. The syringes operate in sizes and configurations not covered by the firm's FDA 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 with no reported illnesses or injuries. The hazard is regulatory non-compliance (devices manufactured outside FDA-cleared specifications) rather than a reported safety incident.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 12,600 non-sterile syringes without needles (Medline brand, Model 91855, Lot 63723100003) distributed across the United States. These syringes are intended for single-use applications.
The recall was issued because the piston syringes supplied operate in sizes and configurations that are outside the range of devices cleared by the FDA under the manufacturer's 510(k) submission. This means the specific configurations were not reviewed and approved by the FDA as safe and effective.
The syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The manufacturer arranged production and shipment through various ports including Shanghai, Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Customers who have received these syringes should contact Jiangsu Shenli Medical or their supplier for instructions on return or replacement of the affected units.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 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: 63723100003
Distribution
Distributed nationwide across the United States.
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