---
title: "8mm FlexDex Needle Driver, Product Code FD-335 ND — FDA record Z-0531-2022 | Is It on Recall"
description: "The firm is reinforcing the IFU instructions: \"Do not use if the package is damaged.\" If upon inspection of the packaging, any damage is observed, including pin"
url: https://isitonrecall.com/recall/fda-device-z-0531-2022-8mm-flexdex-needle-driver-product-code-fd-335-nd/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# 8mm FlexDex Needle Driver, Product Code FD-335 ND — FDA record Z-0531-2022

Reported terminated

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 Dec 22, 2021. 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**: 8mm FlexDex Needle Driver, Product Code FD-335 ND
- **Reason**: The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
- **Classification**: Class II
- **Recalling firm**: FlexDex Inc.
- **Quantity**: 273
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0531-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0531-2022%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 | All lots |

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

## Distribution

Not supplied

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

## Dates in the source

- **Report date**: Feb 2, 2022
- **Recall initiation date**: Dec 22, 2021
- **Center classification date**: Jan 27, 2022
- **Termination date**: Jul 25, 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-0531-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [FlexDex Inc. records](https://isitonrecall.com/brand/flexdex-inc/)