Lower risk Medical device recall · FDA · Published August 23, 2021

Aesthetics Systems Action De Gala and FuSion Gel Recall: Bacterial Contamination Risk

Aesthetics Systems recalls Action De Gala and FuSion Conductive Gels due to potential bacterial contamination. These ultrasound gels may pose health risks if used without proper hygiene.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0029-2022Medical device Aesthetics Systems ›

Lower-risk 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.

Take action

Contact the company

Official pagewww.fda.gov/medical-devices/letter

Recalling firmAesthetics Systems Usa Inc1149 Pomona Rd Ste J · Corona, CA 92882-7600

✎ GovInfoNow plain-language explainer

Aesthetics Systems is recalling Action De Gala and FuSion Conductive Gels because they may contain bacterial contamination. Using these gels without proper hygiene could lead to health risks, especially in medical settings. Read more at govinfonow.com/recall/61915-aesthetics-systems-action-de-gala-and-fusion-gel-recall-bacterial.

Source Summary by GovInfoNow · govinfonow.com/recall/61915-aesthetics-systems-action-de-gala-and-fusion-gel-recall-bacterial · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0029-2022

Cite this page

“Aesthetics Systems Action De Gala and FuSion Gel Recall: Bacterial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61915-aesthetics-systems-action-de-gala-and-fusion-gel-recall-bacterial. Based on FDA recall #Z-0029-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0029-2022%22&limit=1).

Aesthetics Systems Usa Inc recalled Action De Gala and FuSion Conductive gel products due to bacterial contamination risk, according to the FDA on August 23, 2021. The Food and Drug Administration announced the voluntary Class I recall of all lots with valid expiration dates.

How to tell if you have it

Brand: Aesthetics Systems
Products: Action De Gala, FuSion Conductive Gel
Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue
Lots: All lots with valid expiration dates
Quantity: 23 units
Distribution: U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA

The hazard

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall (2026-07-10), Medline Centurion Shave Kits Recall (2026-03-16), and American Contract Systems Medical Kits Recall (2026-05-19).

How to tell if you have this one

Check for the product name 'Action De Gala' or 'FuSion Conductive Gel' with valid expiration dates. The gels are intended for ultrasound transducer use in medical imaging.

Brand
Aesthetics Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Expiration
Verify the expiration date on the gel container to ensure it is valid.
Contact Manufacturer
Reach out to Aesthetics Systems for guidance on handling the gel if you have it.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, California, Texas, Washington.

Recall timeline

FDA published this recall 51 days after the firm started it.

Aug 23, 2021Firm started the recall
Oct 6, 2021FDA classified it Class I
Oct 13, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Take action

Contact Aesthetics Systems

We’ve drafted a message you can send Aesthetics Systems to request your refund or repair — edit it as you like.

✉️ Open in emailCompany site

Subject: Recall Z-0029-2022 — Aesthetics Systems Action De Gala and FuSion Gel Recall: Bacterial Contamination Risk

Hello,

I own a Aesthetics Systems Action De Gala and FuSion Gel Recall: Bacterial Contamination Risk that is covered by recall Z-0029-2022 from Aesthetics Systems.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Link to this recall

<a href="https://govinfonow.com/recall/61915-aesthetics-systems-action-de-gala-and-fusion-gel-recall-bacterial">Aesthetics Systems Action De Gala and FuSion Gel Recall: Bacterial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0029-2022 (August 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0029-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.