Class II

Medical Device Recall: smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

Smiths Medical ASD Inc. · July 18, 2024

Reason for Recall

Uncertainty in the seal integrity of the sterile packaging.

Distribution

Worldwide distribution.

Quantity Affected

27,971 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0146-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.