PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: October 20, 2021 Initiated: August 11, 2021 #Z-0089-2022

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Red Medical Supplies
Units Affected
2000
Distribution
Firm sold product through Amazon.com. Domestic distribution nationwide.
Location
Vancouver, N/A

Frequently Asked Questions

What product was recalled?
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU. Recalled by Red Medical Supplies. Units affected: 2000.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 20, 2021. Severity: Critical. Recall number: Z-0089-2022.