Olympus Ellik Evacuator Model 194: Sterilization Instructions Discrepancy
Olympus recalls Ellik Evacuator model 194 due to differences in sterilization instructions between Japanese packaging and English product manuals. All units are affected.
Lower-risk recall
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Contact the company
What happened, in plain English
Olympus is recalling its Ellik Evacuator model 194 because sterilization instructions in Japanese packaging differ from those in English product manuals. This discrepancy could lead to improper sterilization if users follow the incorrect instructions. Read more at govinfonow.com/recall/52015-olympus-ellik-evacuator-model-194-sterilization-instructions-discrepancy.
Source Summary by GovInfoNow · govinfonow.com/recall/52015-olympus-ellik-evacuator-model-194-sterilization-instructions-discrepancy · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2143-2025
Cite this page
“Olympus Ellik Evacuator Model 194: Sterilization Instructions Discrepancy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52015-olympus-ellik-evacuator-model-194-sterilization-instructions-discrepancy. Based on FDA recall #Z-2143-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2025%22&limit=1).
Why it’s dangerous
The sterilization instructions in the Japanese product packaging differ from the English Instructions For Use. If users follow the Japanese instructions, they might not sterilize the device correctly, increasing infection risk.
Who’s affected
Medical professionals using the Ellik Evacuator for surgical procedures are likely affected. Those who follow the Japanese instructions instead of the English ones may face improper sterilization.
How to tell if you have this one
Check for model number 194 on the Ellik Evacuator. All units are affected, including those sold with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Brand
Olympus- Category
Medical device
All 8 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
International distribution to the country of Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2139-2025 | Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.; Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers | 19 units |
| Z-2140-2025 | Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.; Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers | 41 units |
| Z-2141-2025 | Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 190A. UDI-DI: 00821925003538. All lot numbers | 16 units |
| Z-2142-2025 | Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 190-4. UDI-DI: 00821925003491. All lot numbers | 1 unit |
| Z-2143-2025 | Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 194. UDI-DI: 00821925002586. All lot numbers | 11 units |
| Z-2144-2025 | Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 194-2. UDI: 00821925002593. All lot numbers | 48 units |
| Z-2145-2025 | Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 190-NRS. UDI-DI: 00821925003521. All lot numbers | 5 units |
| Z-2146-2025 | Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.; Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers | 2 units |
What to do — step by step
Review Instructions For Use
Check the English Instructions For Use for correct sterilization procedures.
How this recall unfolded
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2143-2025 (June 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2143-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.