Class II — Turncare, Inc
| Recalling firm | Turncare, Inc. |
|---|---|
| Registered facility | TURNCARE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 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) |
| Quantity | 1142 units |
| Distribution | US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut. |
| Initiated | 2023-08-10 |
| Classified | 2025-06-12 |
| Recall number | Z-1968-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Turncare, Inc (Z-1968-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96874/
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