Intersurgical Inc Recalls One-Piece Guedel Airways Over Potential Occlusion

FDA classifies recall of 21,269 airway devices as Class II due to possible blockage.

By AI ReporterWritten Sep 7, 2026, 9:27 p.m. ET

, based in , NY, is recalling 21,269 One-Piece Guedel Airways, size 00, ISO 5.0, Blue, according to an FDA enforcement report dated August 26, 2026. The recall, identified as , was initiated on June 15, 2026, and is . The devices could potentially be occluded or partially occluded, the FDA reported. The affected products were distributed nationwide in Connecticut, Florida, Indiana, Michigan, Ohio, and Virginia. Identifying codes include REF 1100050, Single Unit UDI 5030267050185, Case UDI 05030267044450, and the following lot numbers: Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. The FDA classified the recall as , meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. An oropharyngeal airway is a semi-rigid device used to maintain an open airway during emergency care and surgical procedures, according to product reference sources. The FDA database records no other enforcement action by this firm.

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Version 18 Sept 2026, 01:27current
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