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"Unapproved fake or illegitimate knockoffs expose patients to serious safety and efficacy risks," the company says in a statement to TODAY.com

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When combined, these cardioprotective effects compound, offering patients with type 2 diabetes meaningful reductions in overall mortality risk compared to standard care alone

Unapproved device concerns FDA raised concerns about Zoll's RescueNet Live software, stating that if the software analyzes data from a monitoring device and generates a secondary alarm and is not merely receiving and displaying alarms, then it is a medical device and is adulterated because Zoll "does not have an approved application for premarket approval (PMA) in effect." Company responses Zoll submitted multiple responses between May 2025 and April 2026 from various quality assurance personnel

This gradual titration reduces gastrointestinal side effects such as nausea and constipation