FDAClass IIMay 11, 2022

Ultrasonic Gastrovideoscope recall

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Why was Ultrasonic Gastrovideoscope recalled?

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

All serial numbers. GTIN: 04953170356322

Product
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Recalling firm
Olympus Corporation of the Americas
Quantity
731 units
Distribution
Nationwide
Recall date
May 11, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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