CLASS I ONGOING Device recall · Reported 13 Oct 2021 · FDA Enforcement Report
Action De Gala, FuSion Conductive Gel recalled by Aesthetics Systems Usa
Aesthetics Systems Usa is recalling Action De Gala, FuSion Conductive Gel, distributed nationwide in the US. The recall was initiated on 23 Aug 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0029-2022
- FDA event ID
- 88624
- Recalling firm
- Aesthetics Systems Usa, Corona, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Aug 2021
- FDA classified
- 6 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 23 Aug 2021 | Recall initiated by company | |
| 6 Oct 2021 | Classified by FDA | +44 days |
| 13 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Where it was distributed
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Questions about this recall
Is Action De Gala, FuSion Conductive Gel recalled?
Yes. Aesthetics Systems Usa recalled Action De Gala, FuSion Conductive Gel on 23 Aug 2021. The recall is Class I and its status is Ongoing. Recall number Z-0029-2022.
Why was it 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 lots are affected?
All lots with valid expiration dates
Where was it sold?
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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