Life Recovery Systems HD, LLCFebruary 5, 2026

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

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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.

Company: Life Recovery Systems HD, LLC
Inspection Date: February 5, 2026
Product Type: Device
Office: New Jersey District Office
Person: Jaro P. Perera

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ID · 852e668c-ee39-4301-88c3-705398207161