# Major Recall Alert: Intubation Oral/Nasal Endotracheal Tubes Recalled Due to Diameter of Device Smaller than Expected
On March 7, 2025, Smiths Medical announced an urgent recall for select Portex Intubation Oral/Nasal Endotracheal Tubes. This recall addresses a potentially dangerous issue—specific tube sizes (2.0, 2.5, 3.0, and 3.5 mm) have been found to have a smaller diameter than expected. This defect poses serious health risks during critical procedures.
Patients, healthcare providers, and distributors should take immediate steps to address this recall and ensure the safety of all affected individuals.
## Why This Recall is Important
Endotracheal tubes are life-saving medical devices designed to support a patient’s breathing during surgeries or emergencies. However, when the diameter of the device is smaller than expected, it can lead to:
- **Inadequate Ventilation**: Reduced airflow may result in insufficient oxygen levels for the patient.
- **Severe Health Risks**: Patients could experience hypoxia, underdose of oxygen, or cardiopulmonary collapse, increasing the risk of life-threatening complications, including death.
Smiths Medical cited eight reported cases of serious injury potentially linked to this defect. The potential risks make this recall a critical safety concern for both healthcare providers and patients.
## Details of the Recall
The impacted products were manufactured and distributed across a five-year period. Healthcare providers and distributors of Intubation Oral/Nasal Endotracheal Tubes should pay close attention to the following details:
- **Affected Sizes**: 2.0 mm, 2.5 mm, 3.0 mm, and 3.5 mm
- **Manufacturing Period**: October 1, 2019, to October 3, 2024
- **Distribution Period**: October 30, 2019, to December 16, 2024
Smiths Medical has distributed letters to customers and distributors, providing instructions to verify affected products. A comprehensive list of impacted products can be found on the [official ICU Medical website](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-informing-customers-potential-issue-certain). The U.S. Food and Drug Administration (FDA) has been notified to ensure broad awareness.
## What You Should Do
To ensure safety and compliance:
1. **Check for Affected Products**: Cross-check the manufacturing and distribution dates with the information provided by Smiths Medical.
2. **Follow Recall Guidelines**: If your supply includes impacted devices, follow the steps outlined in the notification letter distributed by Smiths Medical.
3. **Avoid Using Affected Tubes**: Halt the use of all recalled tubes immediately to limit risks to patients.
4. **Contact Smiths Medical**: Reach out using the customer service information provided in their letter or visit [ICU Medical's website](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-informing-customers-potential-issue-certain).
5. **Report Adverse Events to the FDA**: Adverse reactions or quality issues can be officially reported via the FDA’s MedWatch Adverse Event Reporting Program (online, by regular mail, or fax).
## Stay Safe – Get Instant Recall Alerts
Safety recalls like this serve as a critical reminder of the importance of staying informed. To ensure you are always up-to-date with product recalls, download our Recall Alert App today. Get immediate notifications about recalls that could impact you or your loved ones.
**Stay vigilant. Stay safe.**
Smiths Medical and the FDA are committed to handling this recall with urgency to protect patients and mitigate further risks. Visit the [FDA's recall page](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-informing-customers-potential-issue-certain) for the latest updates and additional instructions.
*Together, we can ensure better healthcare safety and reliability.*