Recall Z-1289-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-1289-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-02-13. It names one FDA 510(k) clearance: K790312. Product: Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035. Reason: Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-02-13
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K790312 — ENDOTRACHEAL TUBE W/HOLDER & CONNECTORRespiratory Support Products, Inc.·cleared 1979-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

Reason for recall

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Data sourced from openFDA. This site is unofficial and independent of the FDA.