Recall Z-0572-2024— Karl Storz Endoscopy

Name: FDA recall Z-0572-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-24

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2023-10-24. It names one FDA 510(k) clearance: K950976. Product: Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A. Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2023-10-24
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K950976 — KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETSKARL STORZ Endoscopy-America, Inc.·cleared 1995-03-21

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

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

Reason for recall

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

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