FDA recall Z-3209-2024

Product

Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA

Reason for recall

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.

Key facts

Status

Ongoing

Initiation date

2024-08-29

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Commerce City, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3209-2024