FDA recall, , Moderate risk
GVS TM SQ40S Blood Transfusion Filter
The SQ40S Blood Transfusion Filter was released before quality control was complete, so sterility cannot be confirmed.
Summary by Recall Canary from the FDA notice
What happened
GVS TM, Inc, of Covina, California, recalled the SQ40S Blood Transfusion Filter. The recall began November 3, 2025, and was added to the FDA's Enforcement Report on January 22, 2026. The recall involved 2,720 filters.
The reason stated by the agency was that products were released for distribution prior to completion of the required quality control release process, so the sterility assurance cannot be confirmed.
The filters were distributed to Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and District of Columbia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
SQ40S Blood Transfusion Filter
- UDI-DI
- 10887691000666
- Lot code
- 7536142
Recall details
- Company began the recall
- Sold in
U.S.: Idaho, Nevada, South Carolina, Missouri, Texas, Colorado, Maryland, California, Virginia, District of Columbia, Pennsylvania, Illinois, Ohio, Arizona, Florida, Oklahoma, Minnesota, Kentucky, Oregon, Nebraska, North Carolina, Louisiana, Mississippi, Michigan, New York, Georgia, Alabama, Massachusetts
- Company
- GVS TM, IncCovina, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98145
- Recall number
- Z-1157-2026
- Quantity recalled
- 2,720 filters
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
