Aesthetics Systems Usa Inc: Medical Device Recall in 2021 - (Recall #: Z-0029-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: August 23, 2021

Date Posted: October 13, 2021

Recall Number: Z-0029-2022

Event ID: 88624

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.

Status: Ongoing

Product Quantity: 23

Code Information:

All lots with valid expiration dates

Distribution Pattern:

U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.

Voluntary or Mandated:

Voluntary: Firm initiated