MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 classified this as a Class II recall due to regulatory non-compliance (device specifications outside cleared range). No illnesses or injuries have been reported, which per the rubric limits this to at most High severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE non-sterile syringes without needles (Model 91827) because piston syringe sizes and configurations are outside the range of devices cleared under the firm's FDA 510(k) submission. The affected lot codes are 63721070001, 63722030001, 63722050001, 63722120002, and 63723070001.
The recalled product comprises 44,800 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Individuals who have received these syringes should cease use and contact the manufacturer or their healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 44,800
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 (5)
- Lot Code: LOT: 63721070001
- 63722030001
- 63722050001
- 63722120002
- 63723070001
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 · clearance violation
See all →- HighMedline Convenience Kits With Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29
- HighMedline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
FDA (Devices) · 2024-05-29
- ModerateMEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation
FDA (Devices) · 2024-05-29
Similar recalls
- HighMedline Syringes Recalled Due to Leaks, Breakage, and Quality Issues
FDA (Devices) · 2024-06-12
- HighMedline Recalls Sterile Syringes Due to Packaging Seal Voids
FDA (Devices) · 2020-04-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- HighMedline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- ModerateMedline Namic Control Syringes recalled due to rescinded FDA clearance
FDA (Devices) · 2026-04-29