Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128...
FDA Recall #Z-0445-2026 — Class I — October 10, 2025
Product Description
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
Reason for Recall
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
96,406 total units
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;
Code Information
ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D UDI-DI 40198459055301 (case), 10198459055300 (ea) Lots 25GBN602
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated