Recalls and Safety Alerts

Although products are never designed to fail, many device companies will need to execute a recall at some point during their product’s market-tenure. To ensure the highest level of consumer safety with minimal impact on your company’s reputation and bottom line, it’s very important to prepare ahead of time for the inevitable recall, before you are faced with one.

Developing and staging in advance just a few important recall management tools will save you valuable time and expense, and will minimize the adverse product consequences experienced by your customers due to faulty products. ComplianceAcuity has hands-on experience assisting with recalls and can provide you the tools needed to deal with the following recall regulatory requirements:

  • Written Recall Procedures
  • Health Hazard Evaluations
  • Recall classification
  • Consumer notification
  • Agency notification and correspondence
  • Recall Termination
  • Reports of Correction and Removals


“I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues…”

  • Director of Operations, Class II & III Devices