Class II — Potential Health Hazard

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

One-piece Guedel airway Recalled by Intersurgical Inc Due to Potential contamination with small burrs, which if detach...

Date: June 20, 2025
Company: Intersurgical Inc
Status: Ongoing
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 Intersurgical Inc directly.

Affected Products

One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

Quantity: 8,640 pieces

Why Was This Recalled?

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Where Was This Sold?

This product was distributed to 10 states: AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA

Affected (10 states)Not affected

About Intersurgical Inc

Intersurgical Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

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