Recall Z-1066-2022— Karl Storz Endoscopy

Name: FDA recall Z-1066-2022
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: K082046. Product: 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018). 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

K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ Endoscopy-America, Inc.·cleared 2008-10-10

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

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

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.