Ellik Evacuator surgical device recall due to sterilization instruction discrepancy
Olympus Corporation is recalling Ellik Evacuator surgical devices due to discrepancies between sterilization instructions in Japanese product package inserts and the English product Instructions For Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an instruction discrepancy with no reported illnesses or injuries. The hazard is theoretical—a documentation inconsistency between sterilization instructions in two language versions rather than an actively documented safety failure.
Plain-English summary
Olympus Corporation of the Americas is recalling Ellik Evacuator surgical devices (Model Number 194-2). The recall was initiated due to discrepancies between sterilization instructions in the Japanese language product package inserts and the English product Instructions For Use (IFU).
The Ellik Evacuator is a surgical evacuation device compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths. The affected 48 units were distributed internationally to Japan.
The specific discrepancies concern the sterilization instructions provided in the two language versions of the product documentation.
The recalled product
- Product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- instruction-discrepancy
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: 194-2. UDI: 00821925002593. All lot numbers
Distribution
Distribution scope not specified by the agency.
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