Recall Z-1057-2025— Karl Storz Endoscopy

Name: FDA recall Z-1057-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2024-12-19. It names one FDA 510(k) clearance: K233372. Product: KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123. Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2024-12-19
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K233372 — KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG·cleared 2024-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.