Brand Name: Guardian 2 System Product Name: Guardian System 2… — Class II medical device recall Z-1967-2025
Ongoing recall by Turncare, Inc, reported 2025-06-18, distributed nationwide. A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specif
| Recall number | Z-1967-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Turncare, Inc, Pompton Plains, NJ, United States |
| Recall initiated | 2023-11-01 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,081 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860001236453 |
| Serial numbers | 2007.01, 2014.01, 2037.01, 2070.01, 2074.01, 2131.01, 2137.01, 2150.01, 2151.01, 2160.01, 2161.01, 2166.01, 2185.01, 2186.01, 2191.01, 2197.01, 2200.01, 2203.01, 2205.01, 2207.01, 2215.01, 2233.01, 2236.01, 2238.01, 2245.01 and 475 more |
| Model numbers | GS-2.5-C |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1967-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.