Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
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: FDA Class II recall of syringes manufactured outside the manufacturer's FDA 510(k) clearance scope, representing a risk-of-harm situation. No illnesses or injuries have been reported.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling non-sterile syringes (3mL capacity, Model 91840) sold under the MEDLINE brand name. These single-use syringes without needles were distributed in the United States.
The recalled syringes were manufactured in configurations and sizes that exceed the scope of Jiangsu Shenli's FDA 510(k) clearance. This means the products do not conform to FDA-approved specifications and may not meet established safety and quality standards.
The syringes were distributed nationwide, with documented presence in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipments were delivered to destinations including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Customers and healthcare providers who have received these syringes should immediately stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. for return or replacement instructions. All inventory of the recalled product should be identified and removed from service.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 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 · manufacturing non compliance
See all →- ModerateMedline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications
FDA (Devices) · 2024-05-29
- HighUniversal Meditech diagnostic test strips recalled for unauthorized distribution
FDA (Devices) · 2023-11-01
- HighPregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure
FDA (Devices) · 2023-11-01
- HighDiagnostic Test Strips Recalled Due to Manufacturing Documentation Failures and Company Closure
FDA (Devices) · 2023-11-01
- ModerateZee Cold Tabs Recalled for CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16