MEDLINE Non-Sterile Syringes Recalled for Unapproved Sizes and Configuration
Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six 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 2/5 (Moderate).
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 a Class II regulatory compliance recall—the device configurations were not included in the FDA's 510(k) clearance. No illnesses or injuries have been reported, and the source does not identify a specific physical hazard, making this a compliance-based precautionary recall rather than one driven by demonstrated harm.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 230,800 MEDLINE non-sterile syringes (Model 91837) for single use without needles. The syringes are being recalled because their piston sizes and configurations exceed those approved by the FDA under the manufacturer's 510(k) clearance.
The affected units are distributed nationwide, primarily in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recall impacts 18 specific lot codes produced by the manufacturer. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare facilities should stop using syringes from the affected lot codes and contact the manufacturer or their medical supplier for instructions on return or replacement. Specific lot numbers and additional information are available through the FDA website and the manufacturer.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 230,800
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 (19)
- Lot Code: LOT: 63721010004
- 63721040002
- 63721050002
- 63721060001
- 63721070001
- 63721080001
- 63721100001
- 63722050001
- 63722090002
- 63722100003
- 63722120002
- 63723020001
- 63723030001
- 63723050001
- 63723060001
- 63723070001
- 63723090002
- 63723100003
- 63723120002
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 →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL 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
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
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
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- HighMedline procedure packs with syringes recalled due to leaks and breakage
FDA (Devices) · 2024-09-04