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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Q-Stop Suture Retention Device Recalled for Performance Issues

Agency Publication Date: August 15, 2025
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Summary

Drs Vascular, Inc. has recalled 264 units of the Q-Stop Suture Retention Appliance (Model QS) due to performance issues that may affect the device's function. The Q-Stop is a sterile, single-use device used in medical settings to help stop bleeding (hemostasis) after venous access procedures. No incidents or injuries have been reported to date regarding this recall.

Risk

Performance failures in this suture retention device could prevent it from effectively assisting with hemostasis during medical procedures. This could lead to complications such as uncontrolled bleeding or delays in patient care.

What You Should Do

  1. This recall affects the Q-Stop Suture Retention Appliance (Model QS) with Lot Code 00860011629405 (6-pack) or Unit of Use code 10860011629402.
  2. Stop using the recalled device immediately and remove it from active surgical or clinical inventory.
  3. Contact Drs Vascular, Inc. or your authorized distributor to arrange for the return, replacement, or correction of any affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any issues related to this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Q-Stop Suture Retention Appliance
Model / REF:
QS
Lot Numbers:
00860011629405 (6-pack)
10860011629402 (Unit of use)
GTIN:
00860011629405
10860011629402

The device is a sterile, single-use, lightweight appliance made of biocompatible materials used to assist with venous access hemostasis.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97128
Status: Active
Manufacturer: Drs Vascular, Inc
Sold By: Drs Vascular, Inc.
Manufactured In: United States
Units Affected: 264
Distributed To: Arkansas, California, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.