# FDA recall Z-1852-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-03-23.

## Product

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

## Reason for recall

Potential for detachment of a distal tip component of the device during use.

## Distribution

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

## Key facts

- **Recall number:** Z-1852-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-23
- **Report date:** 2026-04-29

- **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-1852-2026

## Citation

> AI Analytics. FDA recall Z-1852-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1852-2026. Source: US FDA. Licensed CC0.

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