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Bagley

Gyrus ACMI, LLC · Model MR-6LA · UDI-DI 00821925006232

FGB Prescription

510(k) clearances

6,637

Adverse events (7 deaths)

Recalls

119

Facilities

Description

Bagley Self-Dilating Autoclavable Semi-Rigid Ureteroscope

Recalls

Date	Firm	Reason
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.
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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Data 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.