The FDA has posted 6 enforcement recalls of tube tracheostomy and tube cuff devices since 2025, including 1 Class I (most serious) recall. Most recent report: Jun 10, 2026.
Due to customer complaint regarding incorrect display box labeling.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respirat…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Tube Tracheostomy And Tube Cuff”). Informational only — verify against the FDA before acting.