FDA-Device2026-08-26Class IIPROCESSING DEFECT
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Hazard
Devices could potentially be occluded or partially occluded.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Affected count
21,269 units
Manufactured in
5010 Campuswood Dr Ste 102, East Syracuse, NY, United States
Products
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2952-2026More Intersurgical recalls
- FDA-Device2026-08-26Intersurgical Guedel Airway size 000 recalled for potential occlusion
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.