Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

FDA device recall Z-2719-2026 · posted 2026-07-10 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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.

Action taken

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

Status

Open, Classified

Product code

KQT

Quantity affected

1,156 units

Distribution

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

Date initiated

2026-05-05

Date posted

2026-07-10

Location

Center Valley, PA