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Silicone Tympanostomy Tubes

by Smith & Nephew Richards, Inc. 510(k)

Active United States Open recall

510(k) K932166

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932166 Date26 Jul 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0707-2025 FDA Class II initiated 19 Nov 2024

    Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

    • Ongoing Z-1004-2024 FDA Class II initiated 11 Dec 2023

    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

Specification

510(k)

510(k) Number
FDA Product Code
ETD
Device Class
Class II
Regulation
21 CFR Part 874.3880
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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