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

• FDA — Conducting a Medical Device Recall
• 21 CFR Part 806 — Corrections and Removals (requires FDA Form 3500F or equivalent MDR report form, depending on whether simultaneous medical device reporting is required)