# FDA recall Z-1809-2024

> **Karl Storz Endoscopy** · Class II · device recall initiated 2024-04-01.

## Product

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

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.

## Key facts

- **Recall number:** Z-1809-2024
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-01
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Segundo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1809-2024

## Citation

> AI Analytics. FDA recall Z-1809-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1809-2024. Source: US FDA. Licensed CC0.

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