Wolf Medical Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 35 mL syringes because their piston sizes and configurations exceed the range cleared by the FDA 510(k) authorization.
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 FDA recall based on regulatory non-compliance. No illnesses, injuries, or documented safety defects are reported in the source. The issue is that device specifications fall outside the cleared range, representing a compliance problem rather than a demonstrated hazard.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Wolf Medical 35 mL (cc) Luer Lock Sterile Latex Free Non Pyrogenic syringes (Model SYR35L). Approximately 483,210 units are affected by this recall.
The syringes are being recalled because their piston sizes and configurations fall outside the range of devices cleared by the FDA through the firm's 510(k) submission. This means the syringes were manufactured in specifications that the FDA did not evaluate or authorize for safety and effectiveness.
Affected product was distributed nationwide with specific distribution in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipments were routed through major U.S. ports and logistics centers including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Customers and healthcare facilities in possession of these syringes should contact Jiangsu Shenli Medical Production Co., Ltd. immediately for instructions regarding further use or product return.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Affected units
- 483,210
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 (11)
- Lot Code: LOT: 20190517
- 20191014
- 20200204
- 20200301
- 20210301
- 20210901
- 20211112
- 20220414
- 20220614
- 20221015
- 20231006
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
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