Health product recall

Ultrasonic Gastrovideoscope

Last updated


Ultrasonic Gastrovideoscope
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Ultrasonic Gastrovideoscope More than 10 numbers, contact manufacturer. GF-UC140P-AL5


Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the OERPRO, would not meet the current FDA guidance for reprocessing validation without further design changes. An ineffectively reprocessed endoscope can present an infection control risk to patients. As a result, OMSC is revising the OER-PRO labelling such that the GF-UC140PAL5 is no longer a compatible endoscope for reprocessing in the OER-PRO. Olympus has not received any reported complaints of infection associated with the GFUC140P-AL5 when reprocessed in the OER-PRO.

Recall start date: Mar 18, 2022

Additional information

Original published date:
Alert / recall type
Health product recall
Health products - Medical devices - Gastroenterology & Urology

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To

Japan, 192-8507

Published by
Health Canada
General public
Health professionals
Recall class
Type II
Identification number