Z-2391-2021Class I

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Name: Z-2391-2021 LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Creator: Athena Medical Products Inc
Published: 2021-08-20
License: https://open.fda.gov/license/

Athena Medical Products Inc / initiated 2021-08-20 / Terminated / root cause: manufacturing process

FDA source

Athena Medical Products Inc began a recall of LiquaSonic Ultrasound Gel 250mL, Model No. 001205 on 2021-08-20. 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 Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2391-2021
Classification: Class I
Status: Terminated
Initiated: 2021-08-20
Posted: 2021-09-09
Terminated: 2023-02-02
Recalling firm: Athena Medical Products Inc
Product: LiquaSonic Ultrasound Gel 250mL, Model No. 001205
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 August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed. Athena will no longer purchase or distribute products manufactured by Eco-Med. If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email [email protected].
Quantity in commerce: 12,240 cases of 12
Distribution: Distributed to one distributor within the US.
Product codes and lots: UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2391-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2391-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-09
Z-2392-2021	Class I	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)