EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device used in invasive gastrointestinal procedures. No illnesses or injuries have been reported, but inadequate sterilization of endoscopes poses a significant infection risk to patients, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope (Model GIF-1TH190) that were distributed nationwide. The recall affects all serial numbers of this model.
The devices are being recalled due to sterilization failures that can occur during reprocessing. When the videoscope is sterilized according to the Reprocessing Manual, inadequate drying time in the endoscope channel can result in sterilization failure, meaning the device may not be properly sterilized before use on patients.
These videoscopes are used in medical facilities for gastrointestinal diagnostic and therapeutic procedures. Healthcare providers and facilities using this model should immediately stop use and contact Olympus Corporation for instructions on device return or replacement.
Patients who have undergone procedures with potentially inadequately sterilized devices should consult their healthcare provider.
The recalled product
- Product
- EVIS EXERA III Gastrointestinal Videoscope
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,687
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. GIF-1TH190
- UDI-DI: 04953170343360
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Same hazard · sterilization failure
See all →- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
- HighMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13