Recall archive / FDA device enforcement
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers... — FDA record Z-1967-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Turncare, Inc
- Quantity
- 1081 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1967-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 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Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 18, 2025
- Recall initiation date
- Nov 1, 2023
- Center classification date
- Jun 12, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.