Wolf Medical Syringes Recalled for Uncleared Size and Configuration Variants
Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.
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: FDA Class II recall for regulatory non-compliance—syringes were marketed in size and configuration variants beyond the scope of the manufacturer's 510(k) authorization.
Plain-English summary
Wolf Medical brand 6 mL Luer Lock syringes (Model SYR06L) are being recalled by Jiangsu Shenli Medical Production Co., Ltd. The syringes, in certain size and configuration variants, fall outside the range of devices cleared under the manufacturer's 510(k) authorization.
The recall involves approximately 454,400 units with lot codes from October 2019 through June 2022 (20191014, 20200204, 20200301, 20211112, 20220414, 20220614, 20221015). These units were distributed nationwide, with documented distribution in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The FDA has classified this as a Class II recall. For questions about affected products, contact the manufacturer at Jiangsu Shenli Medical Production Co., Ltd.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Affected units
- 454,400
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 (7)
- Lot Code: LOT: 20191014
- 20200204
- 20200301
- 20211112
- 20220414
- 20220614
- 20221015
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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