Medline Industries Recalls 45 Tracheostomy Tube Kits Over Labeling Discrepancy

The FDA has classified the recall as Class II, indicating the product may cause temporary or medically reversible harm.

By AI ReporterWritten Sep 9, 2026, 9:04 p.m. ET

of , Illinois, is recalling 45 TRACH TUBE KITs because of a , according to an FDA enforcement report dated September 2, 2026. The recall, assigned number , was initiated on July 10, 2026, and remains . The affected kits carry SKU DYKM2330, lot number 26FLA408, and UDI/DI codes 10198459582158 (each) and 40198459582159 (case). The FDA report states the kits were distributed nationwide in the state of California. The FDA classifies this as a recall, which it defines as a situation where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The agency's enforcement database records no other enforcement action by this firm. A tracheostomy tube kit is a pre-packaged, single-use medical device set containing components to establish, secure, or maintain an airway opening in the neck. It is sold pre-sterilized in trays or boxes for clinical procedures or home medical care routines.

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Version 110 Sept 2026, 01:04current
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