FDAFDA · Food and drugs·Recall number Z-1004-2024
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Published February 14, 2024 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia.
- Lot
- UDI: 00821925031913 Lot Number: SM280573
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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