GVS TM, Inc recalls SQ40S Blood Transfusion Filter

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

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

• FDA enforcement recordOfficial FDA database entry for Z-1157-2026
• FDA 510(k) clearance · K960993The device's official FDA premarket clearance record
• FDA device classification · CAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GVS TM, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.