Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASC

FDA device recall Z-0444-2026 · posted 2025-11-13 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

Safety notice was provided to customers on 10/10/2025. Follow-up "URGENT MEDICAL DEVICE RECALL" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail. Customers were instructed to Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product and destroy affected kits on hand. No products are to be returned to Medline. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-215-FG Recall Code: If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. An expanded "URGENT MEDICAL DEVICE RECALL" notification dated 10/24/2025 was provided to customers on 10/24/25, which included additional affected products. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OEZ

Quantity affected

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;

Date initiated

2025-10-10

Date posted

2025-11-13

Location

Northfield, IL