HIGH

GVS TM Recalls Blood Transfusion Filter Over Sterility Concerns

GVS TM, Inc recalled 2,720 SQ40S Blood Transfusion Filters on November 3, 2025. The recall follows concerns that the sterility assurance cannot be confirmed due to incomplete quality control processes. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
November 3, 2025
Hazard Level
HIGH
Brand
GVS TM
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GVS TM, Inc or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The SQ40S Blood Transfusion Filter is a medical device used to ensure the safety of blood transfusions by filtering out impurities. Hospitals and healthcare providers depend on its sterility for patient safety during transfusions.

Why This Is Dangerous

The filters were released without completing the required quality control checks, compromising their sterility assurance. This increases the risk of infections during medical procedures involving blood transfusions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall could lead to significant safety concerns for patients requiring transfusions and may cause disruptions in medical facilities relying on the affected filters.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device packaging or documentation.
  2. Verify the lot number: 7536142.
  3. Consult your healthcare provider for additional guidance.

Where to find product info

Look for the UDI-DI code and lot number on the device packaging or accompanying documentation.

What timeline to expect

Expect a response from GVS TM regarding refunds or replacements within 4-6 weeks.

If the manufacturer is unresponsive

  • Contact the FDA for assistance.
  • Document all communications with GVS TM.

How to prevent similar issues

  • Always verify the recall status of medical devices before use.
  • Check for visible signs of damage or contamination before using medical devices.
  • Ensure that medical devices have completed quality control checks before distribution.

Documentation advice

Keep records of all communications regarding the recall, including emails, letters, and any response from GVS TM.

Product Details

The affected product is the SQ40S Blood Transfusion Filter with UDI-DI code 10887691000666 and Lot Number 7536142. These filters were distributed in various U.S. states including Texas, California, and New York. No price was specified.

Key Facts

  • Recalled filters: 2,720 units
  • Recall date: November 3, 2025
  • Risk level: High
  • Manufacturer: GVS TM, Inc

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeBlood Transfusion Filter
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Affected States
Nationwide
Report Date
January 28, 2026
Recall Status
ACTIVE

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