FlexDex Inc.: Medical Device Recall in 2022 - (Recall #: Z-0531-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

8mm FlexDex Needle Driver, Product Code FD-335 ND

Product Classification:

Class II

Date Initiated: December 22, 2021

Date Posted: February 2, 2022

Recall Number: Z-0531-2022

Event ID: 89316

Reason for Recall:

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.

Status: Terminated

Product Quantity: 273

Code Information:

All lots

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated