# FDA recall Z-1968-2025

> **Turncare, Inc** · Class II · device recall initiated 2023-08-10.

## Product

Brand Name: Guardian 2 System  Product Name: Guardian System 2 Controller  Model/Catalog Number: GS-2.5-C  Software Version: 2.5.4-69 (Fix)

## Reason for recall

A software update corrected an 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.

## Key facts

- **Recall number:** Z-1968-2025
- **Recalling firm:** Turncare, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-10
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pompton Plains, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1968-2025

## Citation

> AI Analytics. FDA recall Z-1968-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1968-2025. Source: US FDA. Licensed CC0.

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