# FDA recall Z-1616-2023

> **Olympus Corporation of the Americas** · Class III · device recall initiated 2023-03-31.

## Product

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract  Models: NA-U401SX-4022, NA-U401SX-4022-A

## Reason for recall

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

## Distribution

Natiowide Foreign: Canada, Germany

## Key facts

- **Recall number:** Z-1616-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-31
- **Report date:** 2023-05-31

- **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-1616-2023

## Citation

> AI Analytics. FDA recall Z-1616-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1616-2023. Source: US FDA. Licensed CC0.

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