Recall Z-1067-2022— Karl Storz Endoscopy

Name: FDA recall Z-1067-2022
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: K982905. Product: 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (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

K982905 — MVM 7.5 FRENCH FLEXIBLE URETEROSCOPEKarl Storz Endoscopy·cleared 1998-10-05

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

11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (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.