Z-0458-2021Class III

Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist...

Name: Z-0458-2021 Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist...
Creator: Steris Corporation
Published: 2020-10-07
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2020-10-07 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number... on 2020-10-07. FDA classified it as Class III and gives the reason as "Potential for cleaning solution intrusion into endoscope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0458-2021
Classification: Class III
Status: Terminated
Initiated: 2020-10-07
Posted: 2020-11-16
Terminated: 2021-07-14
Recalling firm: STERIS Corporation
Product: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Potential for cleaning solution intrusion into endoscope
Root cause tag: design
FDA root cause: Device Design
Action: Steris issued Urgent Medical Device Recall issued letter on 10/7/20 stating reason for recall, health risk and action to take: Please immediately inspect your facility for affected Leak Test Adapters that connect to Olympus endoscopes. The affected Leak Test Adapters have a white plastic valve connector. If you have this Leak Test Adapter, please disconnect from your Acu-sInQ Complete, destroy, and replace with the new Leak Test Adapter included with this Customer Notification Letter. 2. Please complete the Medical Device Recall Response Form included with this Customer Notification Letter. Your STERIS Sales Representative can assist you should you have any questions while completing the form, or when replacing the Leak Test Adapter. 3. Return the completed Medical Device Recall Response Form to STERIS via one of the following three methods: a. Visit https://www.steris.com/medical-device-recall-response-form and complete the form electronically; b. Scan and email the completed form to [email protected]; or c. Fax the completed form to (440) 392-8963. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Katilin Hawranko, Product Manager at (440) 392-7431, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Quantity in commerce: 293 units:248 units (USA); 45 units OUS
Distribution: Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Product codes and lots: Distributed from May 23, 2017 to June 30, 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2021	Class III	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-16

Product code FEB

K181865Class IIAcu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation / cleared 2018-12-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)