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 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: 2.5.4-59 (Fix) |
| Quantity | 1081 units |
| Distribution | US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut |
| Initiated | 2023-11-01 |
| Classified | 2025-06-12 |
| Recall number | Z-1967-2025 |
| 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-1967-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96873/
Alerts for Turncare, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.