Recall Z-3224-2024— Karl Storz Endoscopy

Name: FDA recall Z-3224-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-23

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2024-07-23. It names one FDA 510(k) clearance: K232370. Product: Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123. Reason: Various medical device product IFUs contain 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: 2024-07-23
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K232370 — Percutaneous Nephroscope SystemKarl Storz SE & CO. KG·cleared 2024-05-01

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: 27830KA, Nephroscope for MIP M, Rx only, CE 0123

Reason for recall

Various medical device product IFUs contain 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.