Karl Storz Endoscopy: Device Recall

Recall #Z-1063-2025 · 12/19/2024

Class II: Risk

Recall Details

Recall Number: Z-1063-2025
Classification: Class II
Product Type: Device
Recalling Firm: Karl Storz Endoscopy
Status: Ongoing
Date Initiated: 12/19/2024
Location: El Segundo, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 180 units

Reason for Recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Product Description

KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Distribution Pattern

US Nationwide distribution.

Other Recalls by Karl Storz Endoscopy

Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

View all recalls by Karl Storz Endoscopy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.