Class II

Medical Device Recall: Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

Turncare, Inc · November 1, 2023

Reason for Recall

A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Distribution

US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut

States Affected

NATIONWIDE

Quantity Affected

1081 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1967-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.