Class 2 Device Recall SQ40S Blood Transfusion Filter

• Date Initiated by Firm: November 03, 2025
• Date Posted: January 22, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1157-2026
• Recall Event ID: 98145
• 510(K)Number: K960993
• Product Classification: Microfilter, blood transfusion - Product Code CAK
• Product: SQ40S Blood Transfusion Filter
• Code Information: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
• FEI Number: 2013342
• Recalling Firm/ Manufacturer: GVS TM, Inc; 1630 W Industrial Park St; Covina CA 91722-3419
• For Additional Information Contact: Jeff Weathers; 516-484-5400
• Manufacturer Reason for Recall: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
• FDA Determined Cause: Process control
• Action: On 11/03/2025, the firm sent via email a "GVS TM Inc Customer Statement" informing customers that GVS TM Inc discovered that some of the products in the affected lot may have been damaged during the transportation process. To avoid any potential risk this damage may pose to the downstream user, the firm is requesting return of the affected products. On 11/18/2025, the firm sent via email a "GVS TM Inc Product Recall Statements" informing customers that the products were distributed before completion of the required quality control release process, including final review of sterilization documentation and Certificate of Analysis. As a result the sterility assurance cannot be confirmed. Customers are instructed to: 1) Return all units of Lot 7536142 to GVS TM Inc - Customer Service using GVS TM FedEx Account 203742698, or 2) Destroy the affected units at their facility according to their internal disposal procedures for medical devices. 3) Confirmation Required - If Returning Product --Quantity returned --Date Shipped Back --Contact Person - If Destroying Product (Proof of Destruction Required) --Signed destruction confirmation --Statement on facility letterhead indicating: ---Quantity destroyed ---Date of Destruction ---Method of disposal ---Name/title of the person performing destruction Upon receipt of the above information, GVS TM Inc will issue replacements or credit depending on customer's preference. Questions - Contact GVS TM Customer Service at customerservice tm.na@gvs.com
• Quantity in Commerce: 2,720 filters
• Distribution: U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAK