Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-08-26
FDA class
Class II

Why it was recalled

Hazard

Devices could potentially be occluded or partially occluded.

Product description

Devices could potentially be occluded or partially occluded.

Affected products

REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.

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