FDA-Device2023-09-06Class II
Visera Hysterovideoscope Olympus HYF Type V
Hazard
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Sold states
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.
Affected count
363 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Visera Hysterovideoscope Olympus HYF Type V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2023More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief