Class IIDeviceOngoing

Intersurgical Inc

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

Reason for recall

Devices could potentially be occluded or partially occluded.

Details

Recall number: Z-2952-2026
Event ID: 99284
Recall initiated: Jun 15, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 21,269 units
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: East Syracuse, NY, United States
Lot / code info: REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.