Reported Feb 2, 2022 · Terminated

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

FlexDex Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: FlexDex Inc. · 10421 Citation Dr Ste 900 · Brighton, MI · 48116-6558

Is this the product you have?

    • 8mm FlexDex Needle Driver
    • Product Code FD-335 ND
Lot codes and dates
  • All lots
Amount recalled
273

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 25, 2023 · Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.