Brand Name: Guardian 2 System recallZ-1967-2025 · Turncare, Inc · initiated Nov 1, 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 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 June 2023 and November 2023 software updates to resolve the issue were performed by TurnCare on affected units. The 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. Successful update of the software was verified on each affected controller.
Recall details
- Recall number
- Z-1967-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 1, 2023
- Posted by the FDA
- Jun 12, 2025
- Recalling firm
- Turncare, Inc
- Quantity
- 1081 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: 2.5.4-59 (Fix)
Code information (models, lots, serial numbers)
Show the full code information (11k characters)
Model/Catalog Number: GS-2.5-C; Software Version: 2.5.4-59 (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, 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, 2976.2.2.3, 2978.2.2.3, 3001.2.2.3, 3013.2.2.3, 3034.2.2.3, 3048.2.2.3, 3055.2.2.3, 3056.2.2.3, 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, 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, 2776.2.2, 2777.2.2.3, 2780.2.2, 2781.2.2, 2784.2.2, 2786.2.2, 2787.2.2, 2791.2.2, 2792.2.2, 2793.2.2, 2794.2.2, 2795.2.2, 2796.2.2, 2797.2.2, 2799.2.2, 2800.2.2, 2801.2.2, 2802.2.2, 2803.2.2, 2805.2.2, 2807.2.2, 2808.2.2, 2809.2.2.3, 2810.2.2, 2811.2.2, 2813.2.2, 2814.2.2, 2815.2.2, 2816.2.2, 2817.2.2, 2818.2.2.3, 2821.2.2, 2823.2.2, 2825.2.2, 2832.2.2.3, 2834.2.2, 2835.2.2, 2837.2.2, 2838.2.2, 2839.2.2, 2840.2.2, 2841.2.2, 2843.2.2, 2845.2.2, 2847.2.2, 2848.2.2, 2851.2.2, 2853.2.2, 2854.2.2, 2858.2.2, 2872.2.2, 2876.2.2.3, 2877.2.2.3, 2894.2.2, 2895.2.2.3, 2897.2.2, 2900.2.2.3, 2904.2.2, 2906.2.2, 2907.2.2, 2908.2.2, 2909.2.2, 3000.2.2.3, 3007.2.2.3, 3023.2.2.3, 4017.2.5, 4019.2.5, 4022.2.5, 4023.2.5, 4025.2.5, 4027.2.5, 4032.2.5, 4034.2.5, 4035.2.5, 4037.2.5, 4041.2.5, 4043.2.5, 4044.2.5, 4045.2.5, 4047.2.5, 4049.2.5, 4050.2.5, 4051.2.5, 4052.2.5, 4053.2.5, 4054.2.5, 4055.2.5, 4057.2.5, 4058.2.5, 4059.2.5, 4061.2.5, 4062.2.5, 4063.2.5, 4064.2.5, 4065.2.5, 4066.2.5, 4067.2.5, 4069.2.5, 4070.2.5, 4071.2.5, 4072.2.5, 4073.2.5, 4074.2.5, 4075.2.5, 4077.2.5, 4078.2.5, 4079.2.5, 4080.2.5, 4081.2.5, 4082.2.5, 4083.2.5, 4085.2.5, 4086.2.5, 4087.2.5, 4088.2.5, 4089.2.5, 4090.2.5, 4091.2.5, 4092.2.5, 4093.2.5, 4094.2.5, 4095.2.5, 4096.2.5, 4097.2.5, 4098.2.5, 4099.2.5, 4100.2.5, 4101.2.5, 4102.2.5, 4103.2.5, 4104.2.5, 4105.2.5, 4106.2.5, 4107.2.5, 4108.2.5, 4109.2.5, 4110.2.5, 4111.2.5, 4112.2.5, 4113.2.5, 4114.2.5, 4115.2.5, 4117.2.5, 4118.2.5, 4119.2.5, 4120.2.5, 4121.2.5, 4122.2.5, 4124.2.5, 4125.2.5, 4126.2.5, 4127.2.5, 4128.2.5, 4129.2.5, 4130.2.5, 4131.2.5, 4132.2.5, 4133.2.5, 4134.2.5, 4136.2.5, 4137.2.5, 4139.2.5, 4140.2.5, 4173.2.5, 4178.2.5, 4179.2.5, 4180.2.5, 4181.2.5, 4182.2.5, 4183.2.5, 4184.2.5, 4185.2.5, 4186.2.5, 4187.2.5, 4188.2.5, 4189.2.5, 4190.2.5, 4191.2.5, 4192.2.5, 4193.2.5, 4194.2.5, 4195.2.5, 4196.2.5, 4197.2.5, 4198.2.5, 4199.2.5, 4201.2.5, 4202.2.5, 4203.2.5, 4204.2.5, 4205.2.5, 4206.2.5, 4207.2.5, 4208.2.5, 4209.2.5, 4210.2.5, 4211.2.5, 4212.2.5, 4214.2.5, 4217.2.5, 4219.2.5, 4220.2.5, 4221.2.5, 4222.2.5, 4228.2.5, 4229.2.5, 4230.2.5, 4231.2.5, 4232.2.5, 4233.2.5, 4234.2.5, 4235.2.5, 4236.2.5, 4237.2.5, 4238.2.5, 4239.2.5, 4240.2.5, 4241.2.5, 4242.2.5, 4245.2.5, 4246.2.5, 4247.2.5, 4248.2.5, 4249.2.5, 4250.2.5, 4252.2.5, 4254.2.5, 4255.2.5, 4256.2.5, 4258.2.5, 4259.2.5, 4260.2.5, 4261.2.5, 4262.2.5, 4263.2.5, 4270.2.5, 4277.2.5, 4278.2.5, 4279.2.5, 4280.2.5, 4282.2.5, 4284.2.5, 4285.2.5, 4287.2.5, 4289.2.5, 4294.2.5, 4304.2.5, 4306.2.5, 4310.2.5, 4311.2.5, 4314.2.5, 4315.2.5, 4317.2.5, 4318.2.5, 4319.2.5, 4320.2.5, 4322.2.5, 4323.2.5, 4324.2.5, 4325.2.5, 4326.2.5, 4327.2.5, 4328.2.5, 4330.2.5, 4331.2.5, 4333.2.5, 4334.2.5, 4336.2.5, 4337.2.5, 4338.2.5, 4340.2.5, 4341.2.5, 4342.2.5, 4345.2.5, 4347.2.5, 4348.2.5, 4349.2.5, 4351.2.5, 4355.2.5, 4358.2.5, 4359.2.5, 4361.2.5, 4364.2.5, 4366.2.5, 4367.2.5, 4368.2.5, 4370.2.5, 4372.2.5, 4373.2.5, 4375.2.5, 4424.2.5, 4427.2.5, 4428.2.5, 4429.2.5, 4430.2.5, 4431.2.5, 4434.2.5, 4435.2.5, 4436.2.5, 4437.2.5, 4439.2.5, 4443.2.5, 4478.2.5, 4481.2.5, 4484.2.5, 4487.2.5, 4490.2.5, 4491.2.5, 4492.2.5, 4493.2.5, 4494.2.5, 4528.2.5, 4531.2.5, 4533.2.5, 4534.2.5, 4535.2.5, 4536.2.5, 4537.2.5, 4538.2.5, 4539.2.5, 4540.2.5, 4541.2.5, 4542.2.5, 4543.2.5, 4544.2.5, 4545.2.5, 4546.2.5, 4547.2.5, 4548.2.5, 4549.2.5, 4550.2.5, 4554.2.5, 4555.2.5, 4558.2.5, 4560.2.5, 4561.2.5, 4563.2.5, 4564.2.5, 4566.2.5, 4567.2.5, 4570.2.5, 4571.2.5, 4574.2.5, 4575.2.5, 4597.2.5, 4599.2.5, 4610.2.5, 4612.2.5, 4613.2.5, 4614.2.5, 4615.2.5, 4616.2.5, 4617.2.5, 4618.2.5, 4619.2.5, 4620.2.5, 4622.2.5, 4623.2.5, 4624.2.5, 4625.2.5, 4626.2.5, 4651.2.5, 4652.2.5, 4653.2.5, 4654.2.5, 4655.2.5, 4657.2.5, 4659.2.5, 4661.2.5, 4665.2.5, 4682.2.5, 4686.2.5, 4688.2.5, 4690.2.5, 4691.2.5, 4694.2.5, 4695.2.5, 4696.2.5, 4698.2.5, 4699.2.5, 4763.2.5, 4764.2.5, 4765.2.5, 4766.2.5, 4767.2.5, 4768.2.5, 4770.2.5, 4771.2.5, 4772.2.5, 4773.2.5, 4774.2.5, 4775.2.5, 4777.2.5, 4779.2.5, 4780.2.5, 4781.2.5, 4782.2.5, 4783.2.5, 4784.2.5, 4785.2.5, 4786.2.5, 4787.2.5, 4788.2.5, 4789.2.5, 4790.2.5, 4858.2.5, 4892.2.5, 5341.2.5, 5345.2.5, 5354.2.5, 5382.2.5, 5387.2.5, 5390.2.5, 5393.2.5, 5414.2.5, 5416.2.5, 5421.2.5, 5425.2.5, 2131.01, 2150.01, 2233.01, 2238.01, 2549.01, 2575.2.2.3, 2778.2.2, 2782.2.2.3, 2785.2.2.3, 2881.2.2.3, 2940.2.2.3, 2950.2.2.3, 3040.2.2.3, 3065.2.2.3, 4266.2.5, 4267.2.5, 4268.2.5, 4269.2.5, 4276.2.5, 4283.2.5, 4288.2.5, 4290.2.5, 4291.2.5, 4292.2.5, 4295.2.5, 4296.2.5, 4297.2.5, 4298.2.5, 4299.2.5, 4300.2.5, 4301.2.5, 4302.2.5, 4303.2.5, 4307.2.5, 4309.2.5, 4829.2.5, 4846.2.5, 4026.2.5, 4275.2.5, 4346.2.5, 4350.2.5, 4352.2.5, 4353.2.5, 4354.2.5, 4360.2.5, 4363.2.5, 4369.2.5, 4379.2.5, 4380.2.5, 4381.2.5, 4383.2.5, 4384.2.5, 4385.2.5, 4387.2.5, 4392.2.5, 4395.2.5, 4398.2.5, 4399.2.5, 4401.2.5, 4402.2.5, 4416.2.5, 4417.2.5, 4418.2.5, 4419.2.5, 4420.2.5, 4422.2.5, 4433.2.5, 4442.2.5, 4444.2.5, 4447.2.5, 4448.2.5, 4450.2.5, 4454.2.5, 4509.2.5, 4588.2.5, 4590.2.5, 4897.2.5, 2731.2.2, 2754.2.2, 2760.2.2, 2789.2.2, 2852.2.2, 2855.2.2, 2859.2.2, 2860.2.2, 2862.2.2, 2863.2.2, 2864.2.2, 2865.2.2, 2866.2.2, 2867.2.2.3, 2868.2.2, 2869.2.2, 2870.2.2, 2878.2.2, 2879.2.2, 2880.2.2, 2883.2.2, 2884.2.2, 2885.2.2, 2886.2.2.3, 2887.2.2.3, 2888.2.2, 2890.2.2, 2891.2.2, 2892.2.2, 2893.2.2, 2899.2.2, 2910.2.2, 2912.2.2, 2917.2.2, 2918.2.2, 2922.2.2, 4021.2.5, 4028.2.5, 4029.2.5, 4030.2.5, 4031.2.5, 4036.2.5, 4040.2.5, 4068.2.5, 4084.2.5, 4116.2.5, 4135.2.5, 4138.2.5, 4141.2.5, 4142.2.5, 4143.2.5, 4144.2.5, 4145.2.5, 4146.2.5, 4147.2.5, 4148.2.5, 4149.2.5, 4150.2.5, 4151.2.5, 4152.2.5, 4153.2.5, 4154.2.5, 4155.2.5, 4156.2.5, 4157.2.5, 4158.2.5, 4159.2.5, 4160.2.5, 4161.2.5, 4163.2.5, 4164.2.5, 4165.2.5, 4166.2.5, 4167.2.5, 4168.2.5, 4169.2.5, 4170.2.5, 4171.2.5, 4172.2.5, 4174.2.5, 4176.2.5, 4177.2.5, 4223.2.5, 4224.2.5, 4225.2.5, 4226.2.5, 4227.2.5, 4243.2.5, 4244.2.5, 4251.2.5, 4253.2.5, 4264.2.5, 4265.2.5, 4271.2.5, 4273.2.5, 4286.2.5, 4463.2.5, 4467.2.5, 4523.2.5, 4527.2.5, 4532.2.5, 4551.2.5, 4552.2.5, 4553.2.5, 4556.2.5, 4559.2.5, 4562.2.5, 4565.2.5, 4572.2.5, 4573.2.5, 4609.2.5, 4627.2.5, 4628.2.5, 4629.2.5, 4630.2.5, 4631.2.5, 4633.2.5, 4634.2.5, 4636.2.5, 4639.2.5, 4644.2.5, 4648.2.5, 4650.2.5, 4656.2.5, 4658.2.5, 4660.2.5, 4662.2.5, 4663.2.5, 4664.2.5, 4668.2.5, 4669.2.5, 4670.2.5, 4671.2.5, 4672.2.5, 4673.2.5, 4674.2.5, 4676.2.5, 4677.2.5, 4679.2.5, 4680.2.5, 4684.2.5, 4687.2.5, 4689.2.5, 4693.2.5, 4697.2.5, 4701.2.5, 4702.2.5, 4703.2.5, 4704.2.5, 4705.2.5, 4706.2.5, 4707.2.5, 4708.2.5, 4710.2.5, 4711.2.5, 4712.2.5, 4714.2.5, 4715.2.5, 4717.2.5, 4718.2.5, 4719.2.5, 4720.2.5, 4721.2.5, 4722.2.5, 4723.2.5, 4724.2.5, 4725.2.5, 4727.2.5, 4743.2.5, 4744.2.5, 4745.2.5, 4746.2.5, 4853.2.5, 4856.2.5, 4857.2.5, 4860.2.5, 4869.2.5, 4872.2.5, 4873.2.5, 4884.2.5, 4885.2.5, 4890.2.5, 4907.2.5, 4910.2.5, 2014.01, 2137.01, 2166.01, 2207.01, 2215.01, 2255.01, 2258.01, 2262.01, 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, 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, 4827.2.5, 4828.2.5, 4830.2.5, 4831.2.5, 4832.2.5, 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, 4847.2.5, 4848.2.5, 4849.2.5, 4850.2.5, 4879.2.5, 4882.2.5, 2151.01, 2161.01, 2185.01, 2205.01, 2245.01, 2332.01, 2341.01, 2354.01, 2366.01, 2373.01, 2441.01, 2446.01, 2448.01, 2463.01, 2481.01, 2506.01, 2507.01, 2522.01, 2537.01, 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, 2733.2.2, 2735.2.2, 2736.2.2, 2739.2.2, 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, 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, 3039.2.2.3, 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, 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, 4453.2.5, 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, 4400.2.5, 4404.2.5, 4405.2.5, 4406.2.5, 4407.2.5, 4408.2.5, 4409.2.5, 4410.2.5, 4411.2.5, 4414.2.5, 4421.2.5, 4438.2.5, 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, 4643.2.5, 4645.2.5, 4646.2.5, 4666.2.5, 4667.2.5, 4678.2.5, 4681.2.5, 4683.2.5, 4692.2.5, 4700.2.5, 4716.2.5, 4726.2.5, 4731.2.5, 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-CTurncare Inc · Mattress, Air Flotation, Alternating Pressure2 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.
How recalls are matched to devices · Editorial policy · Report an error on this page