Recall Z-1061-2022— Karl Storz Endoscopy

Name: FDA recall Z-1061-2022
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: K945185. Product: CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1. 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

K945185 — CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)KARL STORZ Endoscopy-America, Inc.·cleared 1995-05-03

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

CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1

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.