Home / Recalls / Karl Storz Endoscopy / Z-1061-2025

Z-1061-2025 Class II Ongoing

Recalled by Karl Storz Endoscopy — El Segundo, CA

Recall Details

Product Type
Devices
Report Date
February 5, 2025
Initiation Date
December 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82 units

Product Description

KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

All Lots/UDI:04048551310816

Other recalls by Karl Storz Endoscopy

  • Z-1053-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, (December 19, 2024)
  • Z-1064-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123 (December 19, 2024)
  • Z-1057-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON ST (December 19, 2024)
  • Z-1056-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STE (December 19, 2024)
  • Z-1060-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, Rx (December 19, 2024)
  • Z-1051-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, Rx (December 19, 2024)
  • Z-1063-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERI (December 19, 2024)
  • Z-0837-2025 Class II — Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE (December 19, 2024)
  • Z-1052-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE (December 19, 2024)
  • Z-1058-2025 Class II — KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STE (December 19, 2024)