Z-1809-2024 Class II Ongoing
FDA device recall Z-1809-2024 was initiated by Karl Storz Endoscopy on Apr 1, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 85.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Apr 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85
Product Description
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
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.
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.
Code Information
All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1809-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026