FDA 483 - Life Recovery Systems HD, LLC - February 05, 2026

Life Recovery Systems HD, LLC, a medical device manufacturer in Kinnelon, NJ, received a Form 483 with two observations. The inspection revealed deficiencies in the firm's risk management processes for its ThermoSuit device, indicating inadequate documentation and implementation. Additionally, the firm's verification activities for purchased temperature monitoring probes were found to be insufficient, lacking proper accuracy evaluations.