Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Recall record
Recall number
Z-0442-2026
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
Recall initiated
2025-10-10
Classified by FDA Center
2025-11-13
FDA published
2025-11-19
Recalling firm
Medline Industries, LP
Firm location
Northfield, IL
Operational response
A Class I device recall indicates a strong likelihood of serious adverse
health consequence or death from continued use. Identify affected units
by serial number, lot, or GTIN against your inventory and against
implanted-device patient registry. Pull affected inventory from active
use immediately. For implanted devices, follow the recalling firm’s
patient-notification protocol; in most cases this requires informing
affected patients and their treating physicians directly.