CLASS II ONGOING Device recall · Reported 22 Feb 2023 · FDA Enforcement Report
Evis Exera Iii Colonovideoscope-For endoscopy recalled
Olympus Corporation of the Americas is recalling Evis Exera Iii Colonovideoscope-For endoscopy and endoscopic surgery within the lower, distributed nationwide in the US. The recall was initiated on 21 Dec 2022 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-1132-2023
- FDA event ID
- 91411
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2022
- FDA classified
- 13 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 21 Dec 2022 | Recall initiated by company | |
| 13 Feb 2023 | Classified by FDA | +54 days |
| 22 Feb 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
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
Where it was distributed
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Questions about this recall
Why was it recalled?
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Which lots are affected?
UDI: 04953170202315 Serial number 2807443
Where was it sold?
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
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 26 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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