FDA-Device2026-08-26Class IIPROCESSING DEFECT
Intersurgical Guedel Airway size 000 recalled for potential occlusion
What this means
Intersurgical Inc. is recalling certain one-piece Guedel oropharyngeal airways (size 000, light green, ISO 3.5) because the devices could become partially or fully blocked, which could interfere with airway management. The recall affects 1,575 units distributed in six U.S. states. No injuries have been reported.
- Check if you have an affected device from lot numbers 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, or 32517565.
- Contact Intersurgical Inc. for instructions on how to proceed with affected units.
- Do not use affected devices for airway management until you receive guidance.
The agency's original wording
Hazard
Devices could potentially be occluded or partially occluded.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Affected count
1,575 units
Manufactured in
5010 Campuswood Dr Ste 102, East Syracuse, NY, United States
Products
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2026More Intersurgical recalls
- FDA-Device2026-08-26One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
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