Recall Z-1004-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1004-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-11

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-12-11. It names one FDA 510(k) clearance: K932166. Product: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044. Reason: 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.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-12-11
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K932166 — SILICONE TYMPANOSTOMY TUBESSmith & Nephew Richards, Inc.·cleared 1993-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.