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Dornier MedTech
DORNIER MEDTECH AMERICA, INC. · Model Axis Ureteroscope · UDI-DI 00810116020690
FGB
Prescription
10
510(k) clearances
7,318
Adverse events (7 deaths)
28
Recalls
118
Facilities
Description
Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Channel Width: 1.2 mm, Bending Angle: -275° - +275°, Working Length: 650 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-22 | Boston Scientific Corporation | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail elect |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.