Z-0029-2022Class I

Action De Gala, FuSion Conductive Gel -

Name: Z-0029-2022 Action De Gala, FuSion Conductive Gel -
Creator: Aesthetics Systems Usa Inc
Published: 2021-08-23
License: https://open.fda.gov/license/

Aesthetics Systems USA Inc / initiated 2021-08-23 / Open, Classified / root cause: manufacturing process

FDA source

Aesthetics Systems Usa Inc began a recall of Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue on 2021-08-23. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0029-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-23
Posted: 2021-10-06
Recalling firm: Aesthetics Systems USA Inc
Product: Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/23/2021, recall notices were emailed to customers. Customer were asked to take the following actions: Stop using and discard affected product. If you have further distributed affected product, please notify them at once of this product recall by sharing the recall notification letter. Complete the response form indicating the product and lot numbers identified and the actions taken in the comment section. Customers with questions are encouraged to call the recalling firm at 1-800-332-8763.
Quantity in commerce: 23
Distribution: U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Product codes and lots: All lots with valid expiration dates

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0029-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0029-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-10-13	2021-10-06

Product code ITX

K955246Class IIEcogel 200 Ultrasound GelEco-Med Pharmaceuticals, Inc. / cleared 1996-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)