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RecallWatchMedical Device Safety
Class IIOngoingZ-1967-2025

Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalo…

Turncare, IncPompton Plains, NJ, United StatesReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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)

Lot / code information

Catalog #
GS-2.5-C; Software Version: 2.5.4-59 (Fix)
UDI
(01)00860001236453
Serial #
2007.01, 2037.01, 2070.01, 2074.01, 2160.01, 2186.01 — +1075 moreShow all
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, 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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, 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4369.2.5, …

What the firm 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.

DistributionShow details

US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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