Drug recall
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector…
FDA recall event 95566 · Class II · Karl Storz Endoscopy
Key facts
| Event ID | 95566 |
|---|---|
| Recall numbers | Z-0526-2025 |
| Recalling firm | Karl Storz Endoscopy |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
| Initiation date | Oct 11, 2024 |
| Report date | Dec 4, 2024 |
| City | El Segundo |
| State | CA |
| Country | United States |
| FEI number | 3007475226 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: