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Open, Classified

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

FDA Recall Z-2720-2026 · Posted 2026-07-10

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeKQT
Date Initiated2026-05-05
Product Quantity3,241 units

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.

Firm Action

Olympus 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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K890328ADULT RESECTOSCOPECircon Video · 1990-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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