Intersurgical Inc: Device Recall

Recall #Z-2275-2025 · 06/20/2025

Class II: Risk

Recall Details

Recall Number: Z-2275-2025
Classification: Class II
Product Type: Device
Recalling Firm: Intersurgical Inc
Status: Ongoing
Date Initiated: 06/20/2025
Location: East Syracuse, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,800 pieces

Reason for Recall

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.

Product Description

One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

Distribution Pattern

US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

Other Recalls by Intersurgical Inc

Class II: Risk 06/20/2025

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.
Class I: Dangerous 06/17/2025

Potential for faulty devices as a result of depleted batteries.

View all recalls by Intersurgical Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.