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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb

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 Class 2 Device Recall Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulbsee related information
Date Initiated by FirmMay 05, 2026
Date PostedJuly 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2720-2026
Recall Event ID 98869
510(K)NumberK890328 
Product Classification Evacuator, gastro-urology - Product Code KQT
ProductOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Code Information Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus notified consignees on about 06/05/2026 via Courier, 2-day delivery. Consignees were requested to examine inventory for affected units. If affected units are on hand, replace any existing sterilization instructions for these products with those provided with the notification and add these instructions to any existing copies of the IFU. Consignees were also instructed to acknowledge receipt of the customer letter through the web portal. If affected units were further distributed, Olympus instructed consignees to identify those customers and forward the notification to them. An updated notice was sent to consignees on 06/30/2026 with further clarification regarding instructions to be used to sterilize affected devices going forward.
Quantity in Commerce3,241 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KQT
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