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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Guardian 2 System Controllers Recalled for Missing Battery Alerts

Agency Publication Date: June 12, 2025
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Summary

Turncare, Inc. has recalled approximately 1,142 units of the Guardian System 2 Controller (Model GS-2.5-C) due to a software issue. A software bug prevented "low" and "terminal" battery alerts from appearing on the device screen in specific situations when the controller was not actively running patient therapy. This lack of notification could lead to the device losing power unexpectedly without the user being warned.

Risk

If the battery alerts fail to display, the device may shut down without notice, potentially rendering the system unavailable for patient care when needed. No injuries or incidents have been reported in connection with this issue.

What You Should Do

  1. This recall involves the Guardian System 2 Controller (Model GS-2.5-C) and is part of the Guardian 2 System. Affected devices were corrected by software version 2.5.4-69.
  2. Check the serial number on the device label to determine if your unit is included in this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and contact the manufacturer or your distributor to arrange for a software correction to version 2.5.4-69.
  4. Contact Turncare, Inc. directly for instructions on how to receive the software update.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹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 Controller
Variants: Guardian 2 System
Model / REF:
GS-2.5-C
Serial Numbers (1142):
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
2449.01
2505.01
2524.01
2557.01
2558.01
2576.2.2
2588.2.2.3
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
2706.2.2.3
2737.2.2.3
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
2913.2.2.3
2919.2.2.3
2959.2.2.3
2960.2.2.3
2965.2.2.3
UDI:
00860001236453

Affected units were corrected with software version 2.5.4-69 (Fix).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96874
Status: Active
Manufacturer: Turncare, Inc
Sold By: Authorized distributors; Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 1142 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 ยท 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.