Z-2143-2025Class II

Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus...

Name: Z-2143-2025 Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus...
Creator: Olympus Corporation of the Americas
Published: 2025-06-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-06-18 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths on 2025-06-18. FDA classified it as Class II and gives the reason as "Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2143-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-18
Posted: 2025-07-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Product code: KQT Evacuator, Gastro-Urology
Reason for recall: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
Quantity in commerce: 11 units
Distribution: International distribution to the country of Japan.
Product codes and lots: Model Number: 194. UDI-DI: 00821925002586. All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2140-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2141-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2142-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2143-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2144-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2145-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21
Z-2146-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-21

Product code KQT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)