FDAClass IIFebruary 14, 2024

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM recall

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

Why was Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM recalled?

The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

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?

UDI: 00821925031913 Lot Number: SM280573

Product
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Recalling firm
Olympus Corporation of the Americas
Quantity
600 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia.
Recall date
February 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls