FDA Recalls Wolf Medical Disposable Syringes for Non-Conforming Configurations
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
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 an FDA Class II recall of medical devices with specifications exceeding those cleared by 510(k) approval, presenting a risk-of-harm scenario. Although no illnesses or injuries have been reported, non-conforming device configurations could affect device performance or safety.
Plain-English summary
Wolf Medical WOLF-PAK 1 mL disposable syringes have been recalled because the piston syringe sizes and configurations in the recalled batches exceed those approved under the manufacturer's 510(k) clearance. The devices deviate from specifications that were reviewed and authorized by the FDA.
The recalled product is model SYR01L, a sterile, latex-free 1 mL syringe without a needle, with lot code 20210430 and serial number 850007185411. Approximately 1,001,900 units were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Consumers and healthcare facilities that have received these syringes should stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. with any questions or concerns. The recall addresses a regulatory compliance issue with the device specifications that were cleared for use.
The recalled product
- Product
- Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 1,001,900
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)
- Serial Number: 850007185411 Lot Code: LOT: 20210430
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.
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