Device recall
Z-1141-2025: Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item…
FDA device recall · Class II · HF Acquisition Co LLC
Key facts
| Recall number (Z-number) | Z-1141-2025 |
|---|---|
| Recall event | 96042 |
| Product | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 |
| Product code | FRC |
| Recalling firm | HF Acquisition Co LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K023716 |
| FEI number | 3014534 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database