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FDA Reports Class II Recall of FORWARD Oral Airway Kits

An ongoing recall affects 509 medical airway kits distributed nationwide due to potential tip occlusion.

By AI ReporterWritten Aug 18, 2026, 4:57 a.m. ET
Developing · checked 8h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 18, 2026, 1:37 a.m. ET — checked 8h ago.

On August 12, 2026, the Food and Drug Administration published an enforcement report regarding an recall initiated on July 7, 2026, by . According to the FDA enforcement report, the recall covers of the FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12) under REF Number 1011-40002. The recall was issued because the The affected products contain two specific one-piece Guedel airway components: Size 00, ISO 5.0, blue (Product Code: 1100050) and Size 000, ISO 3.5, light green (Product Code: 1000035). The recall carries a classification and was distributed nationwide across the United States under recall number . The FDA defines as a category used where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. According to registry records at the Wood Library-Museum of Anesthesiology, a Guedel airway is a piece of clinical airway-management equipment placed into the mouth and over the tongue by a clinician, named after anaesthetist Arthur E. Guedel. These items are professional medical equipment supplied to healthcare providers and institutions rather than retail consumers. FDA enforcement records show no other recall actions listed for .

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  1. Version 118 Aug 2026, 08:57current

    First published.

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