FDA recall Z-2518-2021

Product

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

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

Distribution

US nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-08-25

Report date

2021-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2021