FDA recall Z-2480-2023

Product

Visera Hysterovideoscope Olympus HYF Type V

Reason for recall

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

Distribution

US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.

Key facts

Status

Ongoing

Initiation date

2023-07-20

Report date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2023