Wolf Medical 3 mL Syringes Recalled for Out-of-Specification Manufacturing
Jiangsu Shenli Medical is recalling 777,400 Wolf Medical 3 mL syringes (Model SYR03L) manufactured outside FDA clearance scope. Users should discontinue use of affected lot codes.
What this means for you
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 an FDA Class II recall for regulatory non-compliance where devices were manufactured outside cleared specifications. No illnesses, injuries, or hospitalizations have been reported, and the hazard is precautionary rather than based on documented safety failures.
Plain-English summary
Wolf Medical brand 3 mL (cc) Luer Lock syringes without needles (Model SYR03L) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled. The devices were manufactured in sizes and configurations outside the range cleared by the FDA under the firm's 510(k) pre-market notification.
The affected product is non-sterile and intended for single use. A total of 777,400 units were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recalled lot codes are: 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, and 20231006.
Customers who have received affected product should discontinue use and contact their supplier for return instructions. The FDA is working with the manufacturer to address the manufacturing compliance issue.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- non-compliance
- out-of-specification
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 (8)
- Lot Code: LOT: 20191014
- 20200204
- 20200301
- 20210104
- 20210301
- 20221015
- 20230714
- 20231006
Distribution
Distributed nationwide across the United States.
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