Drug recall
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA recall event 89881 · Class II · Karl Storz Endoscopy
Key facts
| Event ID | 89881 |
|---|---|
| Recall numbers | Z-1054-2022, Z-1055-2022 |
| Recalling firm | Karl Storz Endoscopy |
| Product type | Devices |
| Products | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018), 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| Initiation date | Apr 1, 2022 |
| Report date | May 18, 2022 |
| 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: