CLASS II ONGOING Device recall · Reported 29 Jun 2022 · FDA Enforcement Report
Evis Exera II Gastrointestinal Videoscope-indicated recalled
Olympus Corporation of the Americas is recalling Evis Exera II Gastrointestinal Videoscope-indicated for use within the upper digestive, distributed nationwide in the US. The recall was initiated on 22 Apr 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-1275-2022
- FDA event ID
- 90232
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2022
- FDA classified
- 21 Jun 2022
- Reported
- 29 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Masks, Gloves & PPE
Timeline
| 22 Apr 2022 | Recall initiated by company | |
| 21 Jun 2022 | Classified by FDA | +60 days |
| 29 Jun 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Where it was distributed
US Nationwide distribution in the states of AL, FL, NC, NY.
Questions about this recall
Why was it recalled?
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Which lots are affected?
UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
Where was it sold?
US Nationwide distribution in the states of AL, FL, NC, NY.
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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