smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
FDA Recall Z-0146-2025 · Posted 2024-10-23
Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeBYD
Date Initiated2024-07-18
Product Quantity27,971 units
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Firm Action
Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed.
Distributors were directed to notify their customers by forwarding the notice.
Questions - contact [email protected].
Root Cause
Packaging process control
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.