Recall Record

Cincinnati, OH, United States

Athena Medical Products Inc recalls

1 recall recorded since 2018, most recently on 20 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Medical devices

Recall started
20 August 2021
Terminated
2 February 2023
Reason
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.
Distribution
Distributed to one distributor within the US.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2391-2021, Z-2392-2021

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.