Medline Non-Sterile Syringes Recalled for Unapproved Device Configurations
Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.
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 or injuries. The hazard is regulatory non-compliance—the devices' configurations exceed the FDA 510(k) clearance scope—rather than a specific safety defect. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3, and this precautionary, compliance-based recall appropriately scores as 2 - Moderate.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 178,400 non-sterile syringes without needles sold under the Medline brand name, model 91839. The recalled units span multiple lot codes from 63721040002 through 63723110001.
The syringes are being recalled because their sizes and configurations fall outside the scope of devices cleared under the manufacturer's FDA 510(k) application. No illnesses or injuries have been reported.
The affected syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through multiple U.S. ports and distribution centers, including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities using the recalled syringes should stop use immediately. Those with affected units should contact the manufacturer or their distributor for instructions on returns or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 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
- 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 (20)
- Lot Code: LOT: 63721040002
- 63721050002
- 63721070001
- 63721080 001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722030001
- 63722050001
- 63722080 002
- 63722100003
- 63722120002
- 63723020001
- 63723030001
- 63723050001
- 63723060001
- 63723070 001
- 63723090002
- 63723100003
Distribution
Distributed nationwide across the United States.
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