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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GVS TM
- Product type
- Blood Transfusion Filter
- Model numbers
- Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model number on the device packaging or documentation.
- Verify the lot number: 7536142.
- 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.
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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.
Key Facts
- Recalled filters: 2,720 units
- Recall date: November 3, 2025
- Risk level: High
- Manufacturer: GVS TM, Inc
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Safety Guide
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