Guardian System 2 Controller Recalled for Software Alert Failures

Agency Publication Date: June 12, 2025

Summary

Turncare, Inc. is recalling 1,081 units of the Guardian System 2 Controller (Model GS-2.5-C) due to a software defect. The device's screen fails to display "low" and "terminal" battery alerts in specific situations when the controller is not actively running patient therapy. This software issue affects units with software versions prior to the 2.5.4-59 fix. No incidents or injuries have been reported to date.

Risk

Because the controller may not alert users when the battery is critically low, the device could shut down unexpectedly without warning. This could lead to a delay or interruption in therapy once a patient needs to use the system.

What You Should Do

This recall involves the Turncare Guardian System 2 Controller, Model GS-2.5-C, with software versions prior to version 2.5.4-59 (Fix).
Identify if your device is affected by checking the model and serial number on the device label. Affected serial numbers include 2007.01, 2037.01, 2070.01, 2074.01, 2160.01, and over 1,000 others. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device.
Contact Turncare, Inc. or your specialty medical distributor to arrange for a software update or correction.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Guardian System 2 Controllerby Turncare

Variants: Guardian 2 System

Model / REF:

GS-2.5-C

Serial Numbers (1081):

2007.01

2037.01

2070.01

2074.01

2160.01

2186.01

2191.01

2197.01

2200.01

2203.01

2236.01

2259.01

2286.01

2299.01

2301.01

2303.01

2384.01

2449.01

2467.01

2505.01

2524.01

2557.01

2558.01

2576.2.2

2588.2.2.3

2589.2.2.3

2591.2.2.3

2606.2.2.3

2615.2.2.3

2630.2.2.3

2645.2.2.3

2655.2.2.3

2658.2.2.3

2666.2.2

2741.2.2.3

2750.2.2.3

2827.2.2.3

2836.2.2.3

2846.2.2.3

2873.2.2

2874.2.2

2875.2.2.3

2898.2.2

2901.2.2.3

2902.2.2

2903.2.2

2911.2.2.3

2913.2.2.3

2919.2.2.3

2959.2.2.3

UDI:

0100860001236453

Affected units require software update to Version 2.5.4-59 (Fix).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96873

Status: Active

Manufacturer: Turncare, Inc

Sold By: Specialty medical distributors

Manufactured In: United States

Units Affected: 1081 units

Distributed To: Texas, Illinois, Pennsylvania, Florida, Connecticut

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Turncare Guardian System 2 Controller, Model GS-2.5-C, with software versions prior to version 2.5.4-59 (Fix).

Identify if your device is affected by checking the model and serial number on the device label. Affected serial numbers include 2007.01, 2037.01, 2070.01, 2074.01, 2160.01, and over 1,000 others. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device.

Contact Turncare, Inc. or your specialty medical distributor to arrange for a software update or correction.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Affected Products

Product: Guardian System 2 Controllerby Turncare

Variants: Guardian 2 System

Model / REF:

GS-2.5-C

Serial Numbers (1081):

2007.01

2037.01

2070.01

2074.01

2160.01

2186.01

2191.01

2197.01

2200.01

2203.01

2236.01

2259.01

2286.01

2299.01

2301.01

2303.01

2384.01

2449.01

2467.01

2505.01

2524.01

2557.01

2558.01

2576.2.2

2588.2.2.3

2589.2.2.3

2591.2.2.3

2606.2.2.3

2615.2.2.3

2630.2.2.3

2645.2.2.3

2655.2.2.3

2658.2.2.3

2666.2.2

2741.2.2.3

2750.2.2.3

2827.2.2.3

2836.2.2.3

2846.2.2.3

2873.2.2

2874.2.2

2875.2.2.3

2898.2.2

2901.2.2.3

2902.2.2

2903.2.2

2911.2.2.3

2913.2.2.3

2919.2.2.3

2959.2.2.3

UDI:

0100860001236453

Affected units require software update to Version 2.5.4-59 (Fix).