Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
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Recall Number
Z-1157-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-03
Reported
2026-01-28
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
Code Info
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.