---
title: "To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... — FDA record Z-1616-2023 | Is It on Recall"
description: "Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance exp"
url: https://isitonrecall.com/recall/fda-device-z-1616-2023-to-be-used-with-ultrasound-endoscopes-for-ultrasound-guided-fine-needle-aspiration-fna-of-submucosal/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural... — FDA record Z-1616-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class III
- **Recalling firm**: Olympus Corporation of the Americas
- **Quantity**: 1297 (Boxes; 5 per Box)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1616-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1616-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Natiowide Foreign: Canada, Germany

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 31, 2023
- **Recall initiation date**: Mar 31, 2023
- **Center classification date**: May 19, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1616-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation of the Americas records](https://isitonrecall.com/brand/olympus-corporation-of-the-americas/)