# FDA recall Z-1157-2026

> **GVS TM, Inc** · Class II · device recall initiated 2025-11-03.

## Product

SQ40S Blood Transfusion Filter

## 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.

## 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

## Key facts

- **Recall number:** Z-1157-2026
- **Recalling firm:** GVS TM, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-03
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Covina, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1157-2026

## Citation

> AI Analytics. FDA recall Z-1157-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1157-2026. Source: US FDA. Licensed CC0.

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