FDA-Device2026-07-22Class IIPROCESSING DEFECT
Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
Nationwide distributionMedical devices
What this means
Olympus has recalled the Ellik Evacuator (Model 194), a medical device used during urological procedures. Some sterilization methods described in the device instructions may not reliably sterilize the device, creating a potential infection risk.
- Stop using the sterilization parameters listed in the device instructions.
- Contact Olympus or your healthcare facility for updated sterilization guidance.
- Verify any Ellik Evacuator units in your facility match Model 194 before use.
The agency's original wording
Hazard
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Affected count
3,241 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2026More Olympus recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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