Medline non-sterile syringes recalled for out-of-specification manufacturing
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
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: This is a Class II recall of a medical device with regulatory non-compliance. No illnesses or injuries have been reported. The hazard is theoretical—devices outside cleared specifications present a potential risk of malfunction, but without reported harm, this meets the rubric criterion for High (3) severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand non-sterile syringes without needles (Model 91862, SYR 20ML/L WHITE HEP FLUSH). The recall involves 400 units with lot code 63722030001.
The syringes are being recalled because their sizes and configurations are outside the range of devices cleared by the FDA under the manufacturer's 510(k) application. This means the devices do not meet FDA-approved specifications for safety and performance.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 400
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: 63722030001
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 · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
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
- HighMedline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29
- ModerateMedline Medical Device Kits With Rescinded FDA Clearances
FDA (Devices) · 2026-04-29
- ModerateMedline Control Syringes, Guidewires, and High-Pressure Tubing 510(k) Rescinded
FDA (Devices) · 2026-04-29