FDA WARNING_LETTER - ZOLL Medical Corporation - April 15, 2025

ZOLL Medical Corporation, located in Chelmsford, MA, received an FDA Warning Letter following an inspection conducted from February 27 through April 15, 2025. The investigation revealed significant quality and safety violations regarding several medical devices, including automated external defibrillators, ventilators, electrodes, and sensors. Under the Federal Food, Drug, and Cosmetic Act, the FDA determined these products were produced under conditions that do not meet current good manufacturing practice requirements. Major issues included a failure to maintain adequate corrective and preventive action (CAPA) procedures, such as ignoring data trends that led to a ventilator recall and failing to investigate burnt pediatric electrodes. The FDA also cited the firm for insufficient design validation regarding MRI compatibility for ventilators and inadequate risk assessments for corrosion in electrodes. Furthermore, ZOLL failed to properly categorize critical suppliers and neglected to report device malfunctions to the FDA within the required 30-day timeframe. The agency also noted that the company"s RescueNet Live software may be operating as an unapproved medical device. ZOLL is required to submit a written response within 15 business days outlining a comprehensive plan and timetable for systemic corrections. These actions must align with the new Quality Management System Regulation (QMSR) standards that became effective in February 2026. Failure to address these violations promptly may result in regulatory actions, including product seizures, injunctions, or civil penalties.