Device recall
Z-0526-2025: 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-0526-2025 |
|---|---|
| Recall event | 95566 |
| Product | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2… |
| Product code | HRX |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030009 |
| FEI number | 3007475226 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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