CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Q-Stop Suture Retention Device recalled by Drs Vascular
Drs Vascular is recalling Q-Stop Suture Retention Device, distributed nationwide in the US. The recall was initiated on 16 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2330-2025
- FDA event ID
- 97128
- Recalling firm
- Drs Vascular, San Jose, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2025
- FDA classified
- 15 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 16 May 2025 | Recall initiated by company | |
| 15 Aug 2025 | Classified by FDA | +91 days |
| 27 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
XXX
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 installed within minutes to assist with venous access hemostasis. Component: No
Where it was distributed
U.S. Nationwide distribution in the states of AR, CA, and NY.
Questions about this recall
Why was it recalled?
XXX
Which lots are affected?
Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Where was it sold?
U.S. Nationwide distribution in the states of AR, CA, and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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