FDA recall Z-2275-2025

Intersurgical Inc · Class II · device

Product

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

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-06-20
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2025