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
- Hazard
- sterilization-failure
- infection-risk
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 category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03