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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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.

The Hazard

The filters may not be sterile, as they were distributed before completing the necessary quality control release process. This poses a high risk of infection to patients receiving blood transfusions.

What to Do

Patients and healthcare providers should stop using the SQ40S Blood Transfusion Filter immediately. Contact GVS TM, Inc or your healthcare provider for further instructions.

Contact Information

For more information, email GVS TM, Inc. Visit the FDA website for additional details about the recall.

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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