Class II — Potential Health Hazard

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

Bivona Uncuffed Wire Endotracheal Tubes Recalled by Smiths Medical ASD Inc. Due to Inadequate pouch seal leading to a compromised sterile...

Date: August 9, 2021
Company: Smiths Medical ASD 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 Smiths Medical ASD Inc. directly.

Affected Products

Bivona Uncuffed Wire Endotracheal Tubes,

Quantity: 2191 devices

Why Was This Recalled?

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smiths Medical ASD Inc.

Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.

Related Recalls

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