# FDA recall Z-0351-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-09-13.

## Product

Brand Name: Olympus  Product Name: Cystoscope Outer Sheath  Model/Catalog Number: WA22810A  Software Version: N/A  Product Description: Outer sheaths can be combined with rigid Telescopes.  Component: N/A

## Reason for recall

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

## Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-0351-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-13
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0351-2025

## Citation

> AI Analytics. FDA recall Z-0351-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0351-2025. Source: US FDA. Licensed CC0.

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