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Olympus Ellik Evacuator Includes Glass Body, Male… recallZ-2720-2026 · Olympus Corporation of the Americas · initiated May 5, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2720-2026
Status
Open, Classified
Initiated by the company
May 5, 2026
Posted by the FDA
Jul 10, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
3,241 units
Product code
KQT
FDA submissions
K890328
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

Product description

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

Code information (models, lots, serial numbers)

Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.

Other devices under the same FDA submission

40 devices cleared under K890328 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98869).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page