Z-2719-2026Class II

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

Name: Z-2719-2026 Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A
Creator: Olympus Corporation of the Americas
Published: 2026-05-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-05-05 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A on 2026-05-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2719-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-05
Posted: 2026-07-10
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Product code: KQT Evacuator, Gastro-Urology
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1,156 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Product codes and lots: Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2719-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2718-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2719-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2720-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2721-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10

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)