CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v recalled
Olympus Corporation of the Americas is recalling Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2467-2023
- FDA event ID
- 92703
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2023
- FDA classified
- 28 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Jul 2023 | Recall initiated by company | |
| 28 Aug 2023 | Classified by FDA | +32 days |
| 6 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recent reports of patient infection.
Product as listed by the FDA
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v recalled?
Yes. Olympus Corporation of the Americas recalled Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v on 27 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2467-2023.
Why was it recalled?
Recent reports of patient infection.
Which lots are affected?
Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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