FDAClass IIINovember 25, 2020

Olympus Leak Test Adapter used with Acu-sInQ Complete recall

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

Why was Olympus Leak Test Adapter used with Acu-sInQ Complete recalled?

Potential for cleaning solution intrusion into endoscope

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Distributed from May 23, 2017 to June 30, 2020

Product
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part…
Recalling firm
Steris Corporation
Quantity
293 units:248 units (USA); 45 units OUS
Distribution
Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Recall date
November 25, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls