Device recall
Z-2041-2025: HardyCHROM CRE, selective and differential culture medium for antimicrobial…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-2041-2025 |
|---|---|
| Recall event | 96843 |
| Product | HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 |
| Product code | JSO |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190553 |
| FEI number | 2022807 |
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