Stop using nowMedical device recall · FDA · Published May 5, 2026
Olympus Ellik Evacuator: Sterilization Risk - Stop Using Now
Olympus recalls Ellik Evacuator model 194 due to potential failure to sterilize properly. Affected units may not be sterile after use, risking infection. Stop using immediately.
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.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus Ellik Evacuator: Sterilization Risk - Stop Using Now.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49215-olympus-ellik-evacuator-sterilization-risk-stop-using-now. Based on FDA recall #Z-2720-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2720-2026%22&limit=1).
The FDA announced on May 5, 2026, that Olympus Corporation of the Americas is recalling Model Number 194 Olympus Ellik Evacuators due to potential sterilization failures. The agency stated that some sterilization parameters in the Instructions for Use may not consistently render the devices adequately sterile.
How to tell if you have it
Brand: Olympus
Product: Olympus Ellik Evacuator (Includes Glass Body, Male Connecting Tubing & Latex Bulb)
Model Number: 194
UDI-DI: 0082192500586
Lot Numbers: All Lot Numbers
Units affected: 3,241 units
Sold: US Nationwide and in Canada, Japan, EU, and Latin America
The hazard
The FDA said some sterilization parameters included in the Instructions for Use may not consistently render the devices adequately sterile. Therefore, the agency stated these devices should no longer be used to sterilize the products.
Context
GovInfoNow's records show Olympus Corporation of the Americas has had 133 other recalls on record since August 18, 2017. Other recent recalls by the brand include an Olympus Tripp-Lite P580-025 DisplayPort Cable (August 27, 2026), an Olympus M3 Gold Autoclavable Lateral Telescope (August 24, 2026), and an Olympus BiCOAG Hemostasis Probe (August 19, 2026). Other recent recalls of similar products include Medline Convenience Kits regarding contaminated sterilized products (January 7, 2026) and sterility risk from calibration issues (January 7, 2026).
How to tell if you have this one
Check for the model number 194 on the glass body. The product includes a glass body, male connecting tubing, and latex bulb. All lot numbers are affected.
Brand
Olympus
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Recall number
Product, codes & lots
Quantity
Z-2718-2026
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.; Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
190 units
Z-2719-2026
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.; Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
1,156 units
Z-2720-2026
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.; Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
3,241 units
Z-2721-2026
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.; Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
3,663 units
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the Olympus Ellik Evacuator model 194 as it may not sterilize properly.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2720-2026 (May 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2720-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.