Olympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall affecting a critical medical device used in surgical procedures. Inadequate sterilization poses a direct risk of device-related infection or harm if the device is used with improper sterilization parameters, meeting the Severe criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator, Model Number 194, a medical device that includes a glass body, male connecting tubing, and latex bulb. The recall affects 3,241 units distributed nationwide in the US and in Canada, Japan, the European Union, and Latin America.
The device is being recalled because some sterilization parameters included in the instructions for use may not consistently render the devices adequately sterile. These sterilization parameters should no longer be used to sterilize the devices.
Patients and healthcare providers who have received or are using this device should consult the FDA website or contact Olympus Corporation of the Americas for guidance on proper sterilization procedures or device replacement. The product is identified by Model Number 194 and UDI-DI 0082192500586, and all lot numbers are affected.
The recalled product
- Product
- Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,241
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: 0082192500586. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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