Olympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
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 involving a medical device where sterilization may be inadequate, creating a direct risk of harm (contamination/infection) to patients. No illnesses or injuries are reported in the source text, but the potential for serious harm is inherent in a sterilization failure. This fits the High category criterion for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Glass Body for 194 Ellik Evacuator, Model Number 190A (UDI-DI: 00821925003538) for all lot numbers. Some sterilization parameters included in the instructions for use may not consistently render the devices adequately sterile and should no longer be used to sterilize these devices.
The recalled devices have been distributed worldwide, including to the United States, Canada, Japan, the European Union, and Latin America. A total of 3,663 units are affected by this recall.
Customers using the affected devices should review the sterilization parameters in the instructions for use and discontinue use of any parameters that may not ensure adequate sterilization. Affected users should contact Olympus Corporation of the Americas for updated sterilization instructions and guidance.
The recalled product
- Product
- Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- sterilization-failure
- contamination-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 (1)
- Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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