Recall Z-1068-2022— Karl Storz Endoscopy

Name: FDA recall Z-1068-2022
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: K131369. Product: 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);. 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

K131369 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.·cleared 2013-11-26

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

11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);

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.