Device recall
Z-1658-2025: Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK…
FDA device recall · Class II · Edge Biologicals Inc
Key facts
| Recall number (Z-number) | Z-1658-2025 |
|---|---|
| Recall event | 96497 |
| Product | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations |
| Product code | QMC |
| Recalling firm | Edge Biologicals Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1049818 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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