Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01 Recalled by Summit Medical, Inc. Due to One lot of ventilation tubes have mixed tubes...

Date: May 12, 2014
Company: Summit Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Summit Medical, Inc. directly.

Affected Products

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.

Quantity: 9 boxes

Why Was This Recalled?

One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Summit Medical, Inc.

Summit Medical, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report