FDA 483 - Linde Gas & Equipment Inc - July 25, 2025

An FDA inspection of Linde Gas & Equipment Inc. in Livingston, TN, revealed critical deficiencies in the manufacturing and distribution of its NOxBOXi Class II medical device. The firm demonstrated repeated failures in corrective and preventive actions, inadequate purchasing controls for its critical supplier, and systemic issues in complaint handling that led to unreported adverse events, including patient death and serious injury. Additionally, a significant field correction for device malfunctions was not reported to the FDA, collectively posing ongoing and severe safety risks to critically ill neonatal patients.