Pompton Plains, NJ, United States
Turncare, Inc recalls
2 recalls recorded since 2018, most recently on 1 November 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 November 2023
- 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.
- Distribution
- US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1967-2025
- 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)
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1968-2025
- 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 terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.