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Recall Observatory FDA recall evidence

Device product

LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Z-1809-2024

April 01, 2024

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 94389
Status
Ongoing
Classification
Class II
Quantity
85
Official record key
device-enforcement:Z-1809-2024

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.