Ellik Evacuator Adapter sterilization instructions differ between Japanese and English
Olympus recalls Ellik Evacuator Adapter 190-NRS due to discrepancies between Japanese and English sterilization instructions that could lead to improper device sterilization.
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 a FDA Class II medical device recall involving sterilization instruction discrepancies that create a risk of improper device sterilization. While no adverse events or injuries have been reported, the discrepancy creates a theoretical risk of harm in a surgical context where proper sterilization is critical to patient safety.
Plain-English summary
Olympus Corporation of the Americas is recalling the Ellik Evacuator Adapter, Locking (Model 190-NRS), distributed internationally to Japan, due to discrepancies between sterilization instructions provided in the Japanese language product package inserts and those in the manufacturer's official Instructions For Use (IFU).
The discrepancy in sterilization instructions could potentially result in improper sterilization of the device if users follow the incorrect instructions. Proper sterilization is critical for medical devices used in urological procedures to prevent patient infection and ensure safe patient care.
Affected users, particularly healthcare facilities in Japan using this adapter with Gyrus ACMI Elite and Elite 2 Resection Sheaths, should verify they are following the sterilization instructions contained in the official manufacturer Instructions For Use. Facilities should discontinue use of any instructions from the Japanese language package insert that differ from the official IFU.
Healthcare providers should contact Olympus Corporation of the Americas for clarification of the correct sterilization procedures.
The recalled product
- Product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- instruction-discrepancy
- sterilization-error
- infection-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: 190-NRS. UDI-DI: 00821925003521. All lot numbers
Distribution
Distribution scope not specified by the agency.
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