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Field Corrections & Removals

Planning a field correction or removal​

When a device defect or safety issue is identified, the manufacturer should:

  1. Assess the health hazard — probability and severity of adverse effects
  2. Determine the scope — number of devices affected, distribution chain
  3. Decide on strategy — correction in field, return to manufacturer, destruction
  4. Draft customer notification — recall notice describing the issue, risk, and required actions
  5. Notify FDA — within 10 working days of initiating the action (21 CFR Part 806)

FDA notification content​

The 21 CFR Part 806 report to FDA must include:

  • Device identification (name, model, lot/serial numbers, UDI)
  • Description of the event that prompted the action
  • Manufacturer's evaluation of the risk
  • Number of devices in distribution
  • Distribution pattern (domestic and international)
  • Corrective action being taken
  • Contact person

Customer (consignee) notification​

The recall notification letter must:

  • Clearly identify the affected device(s)
  • Describe the problem and risk
  • Specify the action required by the customer
  • Provide a contact person and deadline
  • Include a reply form for effectiveness check purposes

Effectiveness checks​

FDA expects manufacturers to track recall effectiveness — confirming that customers have received, understood, and acted on the recall notice. Effectiveness check methods include:

  • Reply cards / forms
  • Phone follow-up
  • On-site verification for high-risk (Class I) situations

Official resources​