Karl Storz Endoscopy: Medical Device Recall in 2024 - (Recall #: Z-1809-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2024.
Data Source: FDA.
Product Description:
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Product Classification:
Class II
Date Initiated: April 1, 2024
Date Posted: May 22, 2024
Recall Number: Z-1809-2024
Event ID: 94389
Reason for Recall:
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Status: Ongoing
Product Quantity: 85
Code Information:
All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860
Distribution Pattern:
Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
Voluntary or Mandated:
Voluntary: Firm initiated