FlexDex Needle Driver Recall: Stop Using Damaged Packaging

Take action

Contact the company & request your remedy

Recalling firmFlexDex Inc.10421 Citation Dr Ste 900 · Brighton, MI 48116-6558

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

FlexDex Inc. is recalling all 8mm FlexDex Needle Drivers with product code FD-335 ND because damaged packaging could lead to injury. If the packaging has pinholes or tears, do not use the product.

Why it’s dangerous

The hazard occurs if the packaging is damaged, such as having pinholes or tears. This could lead to injury if the product is used without proper packaging protection.

Who’s affected

Users of the 8mm FlexDex Needle Driver (FD-335 ND) are affected. Those who have the product and inspect the packaging for damage are most at risk.

How to tell if you have this one

Check for pinholes or tears in the packaging pouch. The product is identified by the brand FlexDex and product code FD-335 ND.

Brand
FlexD: Inc.
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging for Damage
Inspect the packaging for pinholes or tears in the pouch. If damage is found, do not use the product.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to the risk of injury if the packaging is damaged, such as having pinholes or tears in the pouch.

What should I do if I have this product?

If the packaging has pinholes or tears, do not use the product. Otherwise, it is safe to use.

Is there a fix for this issue?

The official notice does not mention a fix or remedy for this issue.

Take action

Contact FlexD: Inc.

We’ve drafted a message you can send FlexD: Inc. to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0531-2022 — FlexD: Inc. FlexD: Inc.

Hello,

I own a FlexD: Inc. that is covered by recall Z-0531-2022 from FlexD: Inc..

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0531-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0531-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Use caution until it’s fixed