Drug recall
Karl Storz - Endoskope, REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
FDA recall event 95220 · Class II · Karl Storz Endoscopy
Key facts
| Event ID | 95220 |
|---|---|
| Recall numbers | Z-3218-2024, Z-3219-2024, Z-3220-2024, Z-3221-2024, Z-3222-2024, Z-3223-2024, Z-3224-2024, Z-3225-2024 |
| Recalling firm | Karl Storz Endoscopy |
| Product type | Devices |
| Products | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123, Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123, Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123, Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123, Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 and 3 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| Initiation date | Jul 23, 2024 |
| Report date | Oct 2, 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: