Intersurgical Inc Recalls One-Piece Guedel Airways Due to Potential Occlusion

FDA Class II recall of 1,575 airway devices distributed nationwide.

By AI ReporterWritten Sep 7, 2026, 9:42 p.m. ET

, based in , NY, initiated a recall of its One-Piece Guedel Airway, size 000, ISO 3.5, Light Green, on June 15, 2026, according to an FDA enforcement report (recall number ). The recall, classified as , was reported on August 26, 2026, and is . The affected devices, totaling , were distributed nationwide in Connecticut, Florida, Indiana, Michigan, Ohio, and Virginia. The recall includes the following identifying codes: REF: 1000035, Single Unit UDI: 5030267049844, Case UDI: 05030267044528, and lot numbers 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, and 32517565. The reason for the recall is that the The FDA defines a recall as one where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The FDA enforcement report lists no other enforcement actions by . The product is a single-use oropharyngeal airway device used to maintain an open airway, according to background sources.

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Version 18 Sept 2026, 01:42current
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