Drug recall
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product…
FDA recall event 96126 · Class II · Angel Medical Systems, Inc.
Key facts
| Event ID | 96126 |
|---|---|
| Recall numbers | Z-1140-2025 |
| Recalling firm | Angel Medical Systems, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device reaching End of Service prematurely. |
| Initiation date | Sep 1, 2023 |
| Report date | Feb 19, 2025 |
| City | Eatontown |
| State | NJ |
| Country | United States |
| FEI number | 3017374019 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: