DRS Vascular Q-Stop Suture Retention Device Class II Recall
Drs Vascular, Inc. has issued a voluntary recall of 264 units of DRS Vascular Q-Stop Suture Retention Devices distributed nationwide in Arkansas, California, and New York.
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: FDA Class II classification with voluntary firm initiation. No illnesses or injuries have been reported in the available source documentation.
Plain-English summary
The DRS Vascular Q-Stop Suture Retention Device is a sterile, single-use medical device designed to assist with venous access hemostasis, manufactured by Drs Vascular, Inc. The firm has issued a voluntary Class II recall.
The recall affects 264 units with lot code 00860011629405 (6-pack) and unit of use 10860011629402. Distribution was nationwide in Arkansas, California, and New York. The recall was initiated on May 16, 2025, and is ongoing as of the report date of August 27, 2025.
Consumers and healthcare providers who have received these devices should contact Drs Vascular, Inc. for recall instructions and guidance on product return or replacement procedures.
The recalled product
- Product
- Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installe
- Manufacturer
- Drs Vascular, Inc
- Category
- Medical Device — Vascular Access
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)
- Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Distribution
Distributed nationwide across the United States.
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