Drugs & medicalClass II

Turncare, Inc recalls 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)

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.

Read the official notice →
Date
2025-06-18
Country
United States
Brand
Turncare
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)
Classification
Class II
Units
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Turncare recalls

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

    Turncare, Inc recalls 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)

    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 · DeviceTurncare, IncUS Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…Official notice →
All 2 Turncare recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

    BD SWITZERLAND SARL recalls BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

    Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may…

    FDA · DeviceBD SWITZERLAND SARLWorldwide - US Nationwide distribution including in the states of MA, CA, IL,…Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…

    A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  4. US
    Drugs & medicalClass II

    Turncare, Inc recalls 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)

    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 · DeviceTurncare, IncUS Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…Official notice →
  5. US
    Drugs & medicalClass II

    Belmont Instrument LLC recalls Allon 2001. Part Number: 200-00263

    An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the…

    FDA · DeviceBelmont Instrument LLCWorldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM,…Official notice →
  6. US
    Drugs & medicalClass II

    Mobius Mobility LLC recalls iBOT PMD with software version 01.05.24. Personal Mobility Device.

    Software issue that could potentially lead to the device tipping over from Balance Mode.

    FDA · DeviceMobius Mobility LLCUS Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH,…Official notice →
  7. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

    Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove…

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution.Official notice →
See all drugs & medical recalls →