Brand Name: The Guardian System Product Name: The Guardian… — Class II medical device recall Z-1140-2025
Ongoing recall by Angel Medical Systems, Inc., reported 2025-02-19, distributed nationwide. Device reaching End of Service prematurely.
| Recall number | Z-1140-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angel Medical Systems, Inc., Eatontown, NJ, United States |
| Recall initiated | 2023-09-01 |
| Classified | 2025-02-11 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 548 units |
| UPC / GTIN / UDI-DI | 00850012625001 |
| Lot numbers | A1946, A1947, A1948, A1949, A1950, A2003, A2004, A2031, A2032, A2033, A2034, A2035, A2036, A2038, A2039, A2040, A2041, A2042, A2043 |
| Model numbers | AMSG3-E |
Product
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.
Reason for recall
Device reaching End of Service prematurely.
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-1140-2025. 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.