FDAAugust 23, 2021device

Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

What to do

FDA enforcement status: Ongoing

Brands named

aesthetics systemsaesthetics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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