Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance
Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.
What this means for you
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 a medical device distributed outside its approved specifications. While no illnesses or injuries have been reported, syringes with unapproved sizes and configurations represent a risk-of-harm product that could malfunction during use.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Wolf Medical brand 12 mL (cc) Luer Lock syringes (Model SYR12L). The recalled product is a non-sterile, latex-free syringe without needles intended for single use.
The syringes are being recalled because the device sizes and configurations do not match those covered by the manufacturer's FDA 510(k) clearance. This means the products were distributed in specifications not approved by the FDA.
Approximately 724,500 units have been distributed nationwide, primarily in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Affected lot codes include: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, and 20231006.
Customers who have received these syringes should stop using them and contact the manufacturer for replacement or return instructions. The FDA has classified this as a Class II recall. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
- device-malfunction
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
Distributed nationwide across the United States.
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