Recall Z-2467-2023— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-07-27. It names 3 FDA 510(k) clearances: K220587, K202661, K193182. Product: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V. Reason: Recent reports of patient infection..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-27
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
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
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Reason for recall
Recent reports of patient infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.