FDA announces recall of Medline endotracheal tubes after three injuries
Medline has issued a recall on its Sub-G endotracheal tubes with subglottic suction due to a risk of tearing that may result in cuff leakage, deflation, moisture buildup and failure to inflate. The device is used to open the windpipes of patients who need help breathing, including during surgeries alongside with anesthesia. They’re also used in emergency care for patients who need breathing assistance due to heart attacks, pneumonia and severe injuries.
Three patients have been reportedly injured by the defective tubes. While there have been no reported deaths, due to a serious risk of obstructed breathing, cardiac arrest and damage to the trachea, the FDA has given the recall a Class I designation, the most serious type.
The recall was first announced on February 26, 2024, in an emergency recall notice Medline sent to its known customers.
What is being recalled?
All Medline Sub-G endotracheal tubes with subglottic suctioning are being recalled, with the company requesting they be removed from all care settings and supply houses, and subsequently be destroyed immediately. It is possible the faulty devices remain in supply lines despite the February recall.
The full list of defective products and their specific serial numbers can be found here.
Next steps
The Sub-G Endotracheal Tubes need to be destroyed immediately. Medline is asking customers to share the recall notice to aid in their widespread removal from the market.
Customers with defective tubes can contact Medline at 866-359-1704 or recalls@medline.com to initiate a full refund and replacement. A customer response form will need to be filed for reimbursement.
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