Wolf Medical Syringes Recalled for Exceeding Approved Specifications
Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.
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 a risk-of-harm medical device (syringes) where the piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Although no adverse events have been reported, the regulatory non-compliance indicates potential for device malfunction or failure during use.
Plain-English summary
Wolf Medical 20 mL (cc) Luer Lock STERILE LATEX FREE NON-PYROGENIC syringes (Model SYR20L) are being recalled by the U.S. Food and Drug Administration due to regulatory non-compliance. The manufacturer, Jiangsu Shenli Medical Production Co., Ltd., produced approximately 378,900 units with piston syringe sizes and configurations that exceed the range of devices cleared under the firm's 510(k) approval.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Affected lot codes include: 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, and 20231006. The syringes were distributed to customers through various U.S. ports including Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities in possession of these syringes should stop using them and contact their supplier or the manufacturer for instructions on return or replacement. Syringes that do not meet FDA-approved specifications may not perform as intended.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- specification-non-compliance
- device-malfunction-risk
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 (9)
- Lot Code: LOT: 20200204
- 20200301
- 20210301
- 20210901
- 20211112
- 20220414
- 20220614
- 20221015
- 20231006
Distribution
Distributed nationwide across the United States.
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