Class IIDeviceOngoing

Intersurgical Inc

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Reason for recall

Devices could potentially be occluded or partially occluded.

Details

Recall number: Z-2953-2026
Event ID: 99284
Recall initiated: Jun 15, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 1,575 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: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.