Recall Z-2952-2026— Intersurgical Inc

Name: FDA recall Z-2952-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-15

Class II · Ongoing

Class II FDA medical device recall by Intersurgical Inc, initiated 2026-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.. Reason: Devices could potentially be occluded or partially occluded..

Recalling firm: Intersurgical Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-06-15
Firm location: East Syracuse, NY, United States

Product description

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Reason for recall

Devices could potentially be occluded or partially occluded.

Data sourced from openFDA. This site is unofficial and independent of the FDA.