Brand Name: Guardian 2 System recallZ-1968-2025 · Turncare, Inc · initiated Aug 10, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Turncare, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

Between November 2023 and January 2024 software updates to resolve the issue were performed by TurnCare on affected units. Successful update of the software was verified on each affected controller.

Recall details

Recall number: Z-1968-2025
Status: Open, Classified
Initiated by the company: Aug 10, 2023
Posted by the FDA: Jun 12, 2025
Recalling firm: Turncare, Inc
Quantity: 1142 units
Product code: FNM
Distribution: US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.

Product description

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)

Code information (models, lots, serial numbers)

Show the full code information (12k characters)

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, 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2258.01, 2277.01, 2306.01, 2329.01, 2333.01, 2353.01, 2365.01, 2369.01, 2371.01, 2380.01, 2389.01, 2396.01, 2410.01, 2429.01, 2456.01, 2495.01, 2496.01, 2528.01, 2564.01, 2594.2.2.3, 2629.2.2.3, 2742.2.2, 2770.2.2.3, 2806.2.2, 2812.2.2.3, 2916.2.2, 2921.2.2.3, 2926.2.2.3, 2929.2.2.3, 2938.2.2.3, 2942.2.2.3, 2977.2.2.3, 3018.2.2.3, 3047.2.2.3, 3050.2.2.3, 3061.2.2.3, 4004.2.5, 4010.2.5, 4412.2.5, 4462.2.5, 4464.2.5, 4468.2.5, 4471.2.5, 4472.2.5, 4473.2.5, 4482.2.5, 4483.2.5, 4488.2.5, 4500.2.5, 4510.2.5, 4512.2.5, 4516.2.5, 4522.2.5, 4526.2.5, 4576.2.5, 4578.2.5, 4603.2.5, 4605.2.5, 4608.2.5, 4728.2.5, 4729.2.5, 4730.2.5, 4732.2.5, 4733.2.5, 4735.2.5, 4736.2.5, 4737.2.5, 4739.2.5, 4742.2.5, 4749.2.5, 4750.2.5, 4793.2.5, 4798.2.5, 4801.2.5, 4802.2.5, 4810.2.5, 4813.2.5, 4821.2.5, 4822.2.5, 4823.2.5, 4824.2.5, 4828.2.5, 4830.2.5, 4831.2.5, 4833.2.5, 4834.2.5, 4836.2.5, 4837.2.5, 4838.2.5, 4840.2.5, 4842.2.5, 4843.2.5, 4844.2.5, 4845.2.5, 4848.2.5, 4849.2.5, 4850.2.5, 4879.2.5, 4882.2.5, 2185.01, 2205.01, 2245.01, 2332.01, 2354.01, 2366.01, 2373.01, 2441.01, 2446.01, 2448.01, 2481.01, 2506.01, 2507.01, 2522.01, 2567.01, 2570.01, 2586.2.2.3, 2597.2.2, 2599.2.2.3, 2650.2.2, 2673.2.2, 2674.2.2, 2676.2.2, 2677.2.2.3, 2678.2.2, 2679.2.2.3, 2682.2.2, 2685.2.2, 2686.2.2, 2692.2.2, 2693.2.2, 2696.2.2, 2698.2.2, 2700.2.2.3, 2724.2.2.3, 2727.2.2.3, 2733.2.2, 2735.2.2, 2736.2.2, 2739.2.2, 2744.2.2.3, 2746.2.2.3, 2752.2.2, 2757.2.2, 2764.2.2.3, 2773.2.2, 2783.2.2, 2804.2.2.3, 2819.2.2.3, 2828.2.2.3, 2830.2.2.3, 2844.2.2.3, 2856.2.2.3, 2857.2.2.3, 2871.2.2, 2882.2.2.3, 2920.2.2, 2924.2.2.3, 2931.2.2.3, 2934.2.2.3, 2943.2.2.3, 2945.2.2.3, 2946.2.2.3, 2948.2.2.3, 2949.2.2.3, 2971.2.2.3, 2984.2.2.3, 2989.2.2.3, 2990.2.2.3, 2994.2.2.3, 3006.2.2.3, 3010.2.2.3, 3016.2.2.3, 3019.2.2.3, 3022.2.2.3, 3024.2.2.3, 3025.2.2.3, 3028.2.2.3, 3037.2.2.3, 3038.2.2.3, 3043.2.2.3, 3044.2.2.3, 3045.2.2.3, 3046.2.2.3, 3054.2.2.3, 3059.2.2.3, 2572.2.2, 2574.2.2.3, 2605.2.2, 2608.2.2, 2609.2.2, 2612.2.2, 2618.2.2, 2619.2.2, 2623.2.2.3, 2624.2.2, 2626.2.2.3, 2627.2.2, 2628.2.2, 2986.2.2.3, 3004.2.2.3, 4018.2.5, 4038.2.5, 4042.2.5, 4321.2.5, 4356.2.5, 4357.2.5, 4362.2.5, 4382.2.5, 4386.2.5, 4403.2.5, 4426.2.5, 4449.2.5, 4451.2.5, 4452.2.5, 4456.2.5, 4458.2.5, 4459.2.5, 4461.2.5, 4498.2.5, 4504.2.5, 4216.2.5, 4371.2.5, 4376.2.5, 4377.2.5, 4388.2.5, 4389.2.5, 4391.2.5, 4393.2.5, 4397.2.5, 4404.2.5, 4405.2.5, 4406.2.5, 4407.2.5, 4408.2.5, 4409.2.5, 4410.2.5, 4411.2.5, 4413.2.5, 4414.2.5, 4421.2.5, 4438.2.5, 4445.2.5, 4446.2.5, 4455.2.5, 4457.2.5, 4056.2.5, 4489.2.5, 4637.2.5, 4638.2.5, 4640.2.5, 4642.2.5, 4645.2.5, 4646.2.5, 4647.2.5, 4666.2.5, 4667.2.5, 4678.2.5, 4681.2.5, 4685.2.5, 4716.2.5, 4726.2.5, 4731.2.5, 4738.2.5, 4741.2.5;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Guardian GS-2.5-C
Turncare Inc · Mattress, Air Flotation, Alternating Pressure
2 recalls15 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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