Recall Record

Buffalo Grove, IL, United States

AMEDA, INC. recalls

1 recall recorded since 2018, most recently on 10 July 2017. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class III Medical devices

Recall started
10 July 2017
Reason
Two specific lots was incorrectly manufactured containing a UK power adapter.
Distribution
Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-0616-2018

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.