Red Medical Supplies recalls EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

Recall date

August 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0089-2022

FDA classification

Class I

Brand / firm

Red Medical Supplies

Sold / distributed

Firm sold product through Amazon.com. Domestic distribution nationwide.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU