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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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