Eatontown, NJ, United States
Angel Medical Systems, Inc. recalls
1 recall recorded since 2018, most recently on 1 September 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 September 2023
- Reason
- Device reaching End of Service prematurely.
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1140-2025
- 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 patien
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.