SQ40S Blood Transfusion Filter recallZ-1157-2026 · GVS TM, Inc · initiated Nov 3, 2025
Class II Open, Classified All recalls posted in January 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GVS TM, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
FDA root cause category: Process control
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-1157-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 3, 2025
- Posted by the FDA
- Jan 22, 2026
- Recalling firm
- GVS TM, Inc
- Quantity
- 2,720 filters
- Product code
- CAK
- FDA submissions
- K960993
- 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
Product description
SQ40S Blood Transfusion Filter
Code information (models, lots, serial numbers)
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Haemonetics SQ40SHaemonetics Corporation · Microfilter, blood transfusion1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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