FDAFDA · Food and drugs·Recall number Z-1809-2024
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Published May 22, 2024 · Recall initiated: April 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- 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.
- Lot
- All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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