Recall Z-2480-2023— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-07-20. It names 2 FDA 510(k) clearances: K221557, K022445. Product: Visera Hysterovideoscope Olympus HYF Type V. Reason: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-20
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K221557 — Visera Hysterovideoscope Olympus HYF Type V
- K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.