COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason Description
Diameter of Device Smaller than Expected
- Company Name:
- Smiths Medical
- Brand Name:
- Product Description:
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Product Description
Intubation Oral/Nasal Endotracheal Tubes
Company Announcement
MINNEAPOLIS, MN. March 7, 2025 – Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected.
If the diameter of the device is smaller than expected, it may potentially result in inadequate ventilation to the patient, post-insertion of the endotracheal tube. In such situations, the patient may experience hypoxia, underdose, and/or cardiopulmonary collapse which may lead to death. To date, Smiths Medical has received eight (8) reports of serious injury that are potentially related to this issue.
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical’s website here. Products were manufactured from 01 October 2019 to 03 October 2024 and distributed from 30 October 2019 to 16 December 2024.
For further inquiries, please contact Smiths Medical using the information provided below.
The U.S. Food and Drug Administration (FDA) has been notified of this action.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
