Recall Z-1062-2022— Karl Storz Endoscopy

Name: FDA recall Z-1062-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2022-04-01. It names one FDA 510(k) clearance: K131364. Product: 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US. Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2022-04-01
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEKARL STORZ Endoscopy-America, Inc.·cleared 2014-01-02

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

11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US

Reason for recall

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

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