FDA Database Posts Class 1 Recall of Medline Anesthesia Circuit Kits on November 13, Recall Z-0449-2026 Covering Two Lots
The U.S. Food and Drug Administration (FDA) device recall database posted a Class 1 device recall on November 13, 2025, numbered Z-0449-2026 under recall event 97882, naming Medline Industries, LP of Northfield, Illinois, as the recalling firm. The product is an anesthesia circuit kit, product code DYNJAA10230, covering lots 25EBV570 and 25FBT843. The firm initiated the recall on October 10, 2025.
According to the FDA record, the firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120-inch expandable tubing. The record states that the cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. The FDA-determined cause is listed as a nonconforming material or component.
The firm provided a safety notice to customers on October 10 and a follow-up urgent medical device recall notification dated October 21, sent by email and first-class mail. Customers were instructed to immediately check stock for the affected item and lot numbers, quarantine all affected product, and destroy affected kits on hand; no products are to be returned to Medline. Distributors and others who resold or transferred the product are required under FDA regulations to notify recipients of the recall.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 美国海军医护人员对野战麻醉设备进行系统检查，该设备包含麻醉呼吸回路。照片：美国海军 Bernardo Fuller，公共领域，经 Wikimedia Commons / U.S. Navy personnel perform a systems check on a field anesthesia machine with a breathing circuit. Photo: U.S. Navy, public domain, via Wikimedia Commons
