# FDA recall Z-0029-2022

> **Aesthetics Systems Usa Inc** · Class I · device recall initiated 2021-08-23.

## Product

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

## 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

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

## Key facts

- **Recall number:** Z-0029-2022
- **Recalling firm:** Aesthetics Systems Usa Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-23
- **Report date:** 2021-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2022

## Citation

> AI Analytics. FDA recall Z-0029-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0029-2022. Source: US FDA. Licensed CC0.

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