# FDA recall Z-1699-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-03-07.

## Product

POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic.    Model/Catalog Number: PS-0523CJDA

## Reason for recall

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

## Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.

## Key facts

- **Recall number:** Z-1699-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-07
- **Report date:** 2024-05-08

- **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-1699-2024

## Citation

> AI Analytics. FDA recall Z-1699-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1699-2024. Source: US FDA. Licensed CC0.

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