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Recalls & Safety AlertsVersion 6

Olympus Recalls 3,241 Ellik Evacuator Units Over Sterilization Instructions

An FDA enforcement report says some sterilization parameters in the instructions for use may not consistently render the urological devices adequately sterile.

By AI ReporterUpdated Aug 7, 2026, 10:26 a.m. ET
has recalled of the Olympus Ellik Evacuator, according to an FDA enforcement report filed under recall number . The record describes the product as including a glass body, male connecting tubing and latex bulb, model number 194, and lists identifying codes including "Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers." The recall was initiated on 5 May 2026 and reported on 22 July 2026, with distribution listed as "" The action is listed as , and this account is based on a developing record. The reason given in the enforcement report is that "" The FDA classified the action as . Under the agency's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The Ellik evacuator is not a consumer product. Background sources — the William P. Didusch Center for Urologic History and patent literature describing the standard instrument — describe it as a hand-operated surgical instrument used in urology: a hollow, hourglass-shaped glass body of two connected chambers fitted with a rubber squeeze bulb, connecting tubing and a metal connector that attaches it to a resectoscope passed through the urethra during endoscopic urological operations. Squeezing the bulb pumps sterile fluid in and out so that fragments of tissue and clots settle in the lower chamber. The design dates to 1937, when urology resident Milo Ellik had it blown in the glass shop of the University of Iowa's chemistry department; the model 194 kit is a reusable assembly cleaned and steam-sterilised between uses. It is sold through medical-device manufacturers and surgical distributors to hospitals, operating theatres and surgical centres rather than to the public. This background describes the device generally and says nothing about this recall. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:26current

    No new facts in the record; added headline and dek, story text otherwise unchanged.

  2. Version 57 Aug 2026, 12:36

    Device background rewritten to match the cited historical and patent sources, removing unsourced claims about FDA device classification regulations and Ellik's birthplace; source list corrected.

  3. Version 47 Aug 2026, 08:09

    Replaced the AccessGUDID-based device background with the patent, eCFR and Didusch Center sources actually in the fact set, and added the source URLs for the recall record and Class II definition.

  4. Version 37 Aug 2026, 03:06

    Replaced unsourced device background (Didusch Center, 21 CFR 876.4370, reusability/steam-sterilisation claims) with descriptions attributed to AccessGUDID and the cited patents, and added those source URLs.

  5. Version 26 Aug 2026, 22:46

    Rewrote the product-background paragraph to match the cited reference sources, removing unsupported details (chemistry-department glass shop, clinical use claims, disposable versions) and adding the 21 CFR 876.4370 classification and reusable/steam-sterilised handling.

  6. Version 16 Aug 2026, 18:11

    First published.

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