FDAClass ISeptember 15, 2021

LiquaSonic Ultrasound Gel recall: Contamination

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Why was LiquaSonic Ultrasound Gel 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.

Product
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Recalling firm
Athena Medical Products Inc
Quantity
12,240 cases of 12
Distribution
Distributed to one distributor within the US.
Recall date
September 15, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls