CLASS I Device recall · Reported 15 Sep 2021 · FDA Enforcement Report

LiquaSonic Ultrasound Gel recalled by Athena Medical Products

Athena Medical Products is recalling LiquaSonic Ultrasound Gel. The recall was initiated on 20 Aug 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI 00856589006137, All lot codes. Product will be discontinued and will not be reintroduced.

Quantity recalled480 cases of 4

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-2392-2021
FDA event ID: 88540
Recalling firm: Athena Medical Products, Cincinnati, OH
Classification: Class I
Status: Terminated
Recall initiated: 20 Aug 2021
FDA classified: 9 Sep 2021
Reported: 15 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

20 Aug 2021	Recall initiated by company
9 Sep 2021	Classified by FDA	+20 days
15 Sep 2021	Published in enforcement report	+6 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

LiquaSonic Ultrasound Gel 5L, Model No. 001222

Where it was distributed

Distributed to one distributor within the US.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI 00856589006137, All lot codes. Product will be discontinued and will not be reintroduced.

Where was it sold?

Distributed to one distributor within the US.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88540

This product is part of a recall event; the main page for the event is LiquaSonic Ultrasound Gel recalled by Athena Medical Products.

Reported	Class	Recall	Company	Reason	Where
15 Sep 2021	CLASS I	LiquaSonic Ultrasound Gel recalled by Athena Medical Products	Athena Medical Products	Other	OH

More recalls from Athena Medical Products

All 2

Reported	Class	Recall	Company	Reason	Where
15 Sep 2021Device	CLASS I	LiquaSonic Ultrasound Gel recalled by Athena Medical Products	Athena Medical Products	Other	OH

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