Why do certain Medical Device companies Keep Appearing on the FDA Recall List?

If you’ve experienced an FDA recall, that’s usually enough grief & stress to last a lifetime.

So, if you’ve dealt with several recalls (with the same company) it speaks to several likely challenges, and in our experience, they are suffering through the following:

  • Lack of utilization and/or understanding – cost of quality (COQ)risk mitigation patient safety FDA recall
  • Lack of effective Risk Management
    • Minimal ‘out of the box’ Early Risk Identification/Mitigation
    • Ineffective FMEA’s and FTA’s used to reveal blind spots where potential critical defects hide
    • Inability to reveal blind spots where critical defects hide
  • Unexpected Destructive User Interaction
  • Abnormal System Behavior
  • Process improvement is needed – but where?
    • SDLC
    • QMS

When any company repeatedly appears on the FDA’s Recall List, it’s indicative of a culture that is more concerned with “checking the time-to-market box”, than product quality and system reliability.  Patient safety clearly comes in last.

FDA Recall

Why do I say this?  Look at how often you see the same companies on the FDA Recall List.  That’s a culture problem.

This prioritization of teams focusing on getting products to market before their competitors, (means they’re on a serious time crunch), often causes folks to cut corners…or just perform only what is required/expected for ‘compliance to the letter, not, compliance to the intent.‘.  They aren’t going the extra mile.

Compare this to the Boeing 737 Max debacle; they allowed not one, but TWO airliners to crash (killing everyone on board) before they decided to admit THEY had the problem – not the Pilots or anyone else involved with flying/maintaining the aircraft.  They also weren’t thinking out of the box – they wanted to get a new plane to market as quickly as possible, due to global competition. How else do you explain these catastrophes in the modern technological age? Boeing has been building planes for a long time.

This latest Medical Device product pull – came after multiple deaths were reported. Why not before any deaths?  This is 2021, and I believe it’s too costly a process for large medical device manufacturers to (be able to) follow.

Risk ID FDA Recall Prevention

We believe it can be done better…and best practice always wins the day.

If your processes are iron clad, with quality as your north star, you can prevent (or avoid) recalls and other disasters altogether.

Here’s why.

Our approach incentivizes patient safety and product reliability through demonstrable product quality metrics – because the better your development/delivery process gets, the shorter your time-to-market – since the process eliminates costly rework.

Here’s what we’ve learned; by focusing on identifying the high-risk areas in the product/system first – and mitigating critical potential defects early – you put yourself in a position to deliver products your customers Trust

Why operate any other way…?

For more information on our Recall Prevention Program (which utilizes Risk ID) here’s the link.


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