Ellik Evacuator sterilization instructions discrepancy between languages
Olympus recalls Ellik Evacuators due to discrepancies in sterilization instructions between Japanese product inserts and manufacturer documentation. Inconsistent sterilization procedures could affect device safety.
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: FDA Class II medical device with instruction discrepancy that poses risk of improper sterilization in surgical settings. No illnesses or injuries have been reported, but the potential for harm from improperly sterilized surgical instruments qualifies this as a risk-of-harm product.
Plain-English summary
Olympus Corporation of the Americas is recalling Ellik Evacuators (Model 194) due to discrepancies between sterilization instructions provided in Japanese language product package inserts and those published in the manufacturer's Instructions For Use (IFU).
The discrepancy between sterilization instructions in different versions of the product documentation could lead to improper sterilization of the device. Proper sterilization is critical for surgical instruments to prevent infection during medical procedures.
Healthcare facilities that have received this device should verify they are using the correct sterilization instructions from the manufacturer's official IFU. Users should not rely solely on translated product inserts if they contain discrepancies with the official IFU.
Affected devices have Model Number 194 and UDI-DI 00821925002586. The recall affects 11 units distributed to Japan.
The recalled product
- Product
- Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- sterilization-discrepancy
- labeling-inconsistency
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: 194. UDI-DI: 00821925002586. All lot numbers
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03