Device recall
Z-2887-2026: HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-2887-2026 |
|---|---|
| Recall event | 99226 |
| Product | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and… |
| Product code | JTN |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K253105 |
| 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