Z-0146-2025 Class II Ongoing
FDA device recall Z-0146-2025 was initiated by Smiths Medical ASD Inc. on Jul 18, 2024 and is designated Class II. Reason for recall: Uncertainty in the seal integrity of the sterile packaging. The recall status is ongoing. Affected quantity: 27,971 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Jul 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,971 units
Product Description
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0146-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026