FDA recall Z-1157-2026

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

Status

Ongoing

Initiation date

2025-11-03

Report date

2026-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covina, CA, United States

Primary source

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