Lower riskMedical device recall · FDA · Published April 1, 2024
Karl Storz Endoscopy Laser Instruments Risk: Infection from Improper Reprocessing
Karl Storz Endoscopy recalls two laser surgical instruments due to lack of validated reprocessing methods, increasing infection risk after reuse. Affected models include REF 8694 and 461000.
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.
Take action
Contact the company
📍Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017
“Karl Storz Endoscopy Laser Instruments Risk: Infection from Improper Reprocessing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55675-karl-storz-endoscopy-laser-instruments-risk-infection-from-improper-reprocessing. Based on FDA recall #Z-1809-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2024%22&limit=1).
The FDA announced on April 1, 2024, that Karl Storz Endoscopy is voluntarily recalling LASER Application Instruments due to sterility assurance risks. The agency issued recall number Z-1809-2024 for the affected devices distributed worldwide.
How to tell if you have it
Karl Storz Endoscopy LASER Application Instrument, 23 cm, REF: 8694
LEUNIG-GREVERS LASER Application, REF: 461000
The hazard
According to the FDA, these laser surgical instruments lack specific evidence of a validated reprocessing method. Consequently, they lack sterility assurance, creating an increased risk of patient infection exposure after reprocessing and reuse.
Context
GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since 2017-10-10. Recent brand recalls include the Karl Storz HOPKINS Telescope Recall (2026-08-12) and the Karl Storz Flexible Hystero-Fiberscope Kits recall (2026-05-21). Other recent recalls of similar products include the Olympus EVIS EXERA III Duodenoscope Recall (2025-10-14), the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), and the Medline Convenience Kits Recall (2026-01-07).
How to tell if you have this one
Check for the model reference numbers 8694 or 461000 on the instruments. These were sold with specific serial numbers: 8694/04048551216392 and 461000/04048551164860.
Brand
Karl Storz Endoscopy
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Instrument Model
Look for the model reference numbers 8694 or 461000 on the instruments.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Nebraska, New York, Ohio, Texas, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1809-2024 (April 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1809-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.