FDA Medical Device Recalls (openFDA)
Steris Corporation: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
- Recall number
- Z-0458-2021
- 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
- Status
- Terminated
- Initiated
- 2020-10-07
- Posted
- not on file
- Terminated
- 2021-07-14
- Reason
- Potential for cleaning solution intrusion into endoscope
- 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 Regulatory_Compliance@STERIS.com; 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
- 293 units:248 units (USA); 45 units OUS
- Distribution
- Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
- Lot, serial or model codes
- Distributed from May 23, 2017 to June 30, 2020
- 510(k) numbers
- ["K181865"]
- PMA numbers
- not on file
- Product code
- FEB
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28