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.

Smiths Medical ASD Inc. Medical Device Recall: smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000 | SafeCheck