FDA Medical devices recall ·
Guardian 2 System Product Name: Guardian System 2 Controller Model recall
- Recall number
- Z-1968-2025
- Date
- (initiated August 10, 2023)
- Company / brand
- Turncare, Inc
230 W Parkway Ste 6, Pompton Plains, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1142 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: GS-2.5-C; Software Version: 2.5.4-69 (Fix); UDI-DI: (01)00860001236453; Serial Numbers: 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, 2968.2.2.3, 2976.2.2.3, 2978.2.2.3, 3001.2.2.3, 3013.2.2.3, 3017.2.2.3, 3034.2.2.3, 3048.2.2.3, 3055.2.2.3, 2571.2.2, 2573.2.2, 2577.2.2, 2578.2.2.3, 2579.2.2, 2582.2.2.3, 2583.2.2.3, 2585.2.2, 2587.2.2, 2590.2.2, 2592.2.2, 2595.2.2, 2596.2.2, 2598.2.2, 2600.2.2, 2601.2.2, 2602.2.2.3, 2603.2.2, 2604.2.2, 2607.2.2, 2611.2.2.3, 2614.2.2, 2616.2.2, 2617.2.2.3, 2621.2.2, 2622.2.2, 2636.2.2, 2637.2.2, 2639.2.2, 2649.2.2, 2684.2.2, 2691.2.2, 2701.2.2, 2702.2.2, 2703.2.2, 2704.2.2, 2705.2.2, 2709.2.2, 2710.2.2, 2711.2.2, 2712.2.2, 2713.2.2, 2714.2.2, 2716.2.2, 2718.2.2, 2719.2.2, 2720.2.2, 2722.2.2, 2723.2.2, 2725.2.2, 2726.2.2, 2728.2.2, 2730.2.2, 2734.2.2, 2738.2.2, 2748.2.2.3, 2755.2.2, 2758.2.2, 2759.2.2, 2761.2.2, 2762.2.2, 2765.2.2, 2766.2.2, 2767.2.2, 2768.2.2, 2769.2.2, 2771.2.2, 2772.2.2, 2774.2.2, 2775.2.2, 2777.2.2.3, 2780.2.2, 2781.2.2, 2784.2.2, 278
Distribution
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.
States: Connecticut Florida Illinois Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1968-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.