Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a regulatory compliance issue involving medical devices (non-sterile syringes) manufactured in configurations exceeding FDA 510(k) clearance. While no illnesses or injuries have been reported, the product poses a potential risk of harm due to use in unauthorized configurations.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. has recalled Medline brand non-sterile syringes (Model 91879) because the manufacturer produced the device in sizes and configurations that exceed the range cleared under the firm's FDA 510(k) approval.
The syringes were distributed nationwide in the United States, with shipments to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through major ports and distribution centers.
No illnesses or injuries have been reported in connection with this recall. The recall addresses a manufacturing compliance issue where certain device configurations were produced outside the approved regulatory scope.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
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
Part of a larger recall action
This product is one of 87 recalled by Jiangsu Shenli Medical Production Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 87 products in this recall →Related recalls
Same manufacturer · Jiangsu Shenli Medical Production Co., Ltd.
See all →- ModerateWolf Medical Syringes Recalled for Uncleared Size and Configuration Variants
FDA (Devices) · 2024-05-29
- HighMedline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing
FDA (Devices) · 2024-05-29
- HighMedline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing
FDA (Devices) · 2024-05-29
- ModerateMEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance
FDA (Devices) · 2024-05-29
- ModerateMedline Non-Sterile Syringes Recalled for Out-of-Range Sizes and Configurations
FDA (Devices) · 2024-05-29
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01