Steris Corporation: Medical Device Recall in 2020 - (Recall #: Z-0458-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

Product Classification:

Class III

Date Initiated: October 7, 2020

Date Posted: November 25, 2020

Recall Number: Z-0458-2021

Event ID: 86596

Reason for Recall:

Potential for cleaning solution intrusion into endoscope

Status: Terminated

Product Quantity: 293 units:248 units (USA); 45 units OUS

Code Information:

Distributed from May 23, 2017 to June 30, 2020

Distribution Pattern:

Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates

Voluntary or Mandated:

Voluntary: Firm initiated