# FDA recall Z-0109-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-09-12.

## Product

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S  Model: TB-0545FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed

## Reason for recall

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0109-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-12
- **Report date:** 2023-10-18

- **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-0109-2024

## Citation

> AI Analytics. FDA recall Z-0109-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0109-2024. Source: US FDA. Licensed CC0.

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