Recall Record

Commerce City, CO, United States

Microcare Medical recalls

1 recall recorded since 2018, most recently on 29 August 2024. 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 II Medical devices

Recall started
29 August 2024
Reason
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Distribution
Worldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO, NY, MD, CA, MI, NE, UT, OK, WI, NJ, IL, ME, CT, KS, TX, NC, TN, SC, MO and the countries of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-3209-2024

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.