Product Recalls, Removals, and Corrections: Procedures and Best Practices

What You Need to Know? 👇

What information must be submitted to FDA when initiating a medical device recall?

Medical device recalls require comprehensive documentation including product identification (510(k)/PMA numbers, UDI codes), lot/serial numbers, distribution records, reason for recall, health hazard assessment, recall strategy, and direct account consignee lists. Submit information as it becomes available rather than waiting for complete documentation.

How quickly should FDA be notified when a recall decision is made?

FDA should be contacted as soon as a recall decision is made, and if feasible, prior to issuing public notices or customer communications. Expediting recall activities is vital for patient safety and regulatory compliance.

What are the key elements required in recall communications to customers?

Recall communications must include “URGENT: MEDICAL DEVICE RECALL” flagging, accurate product identification with codes, clear problem description, recall depth instructions, specific actions required, and return response cards for confirmation of compliance.

What is the difference between voluntary and mandatory medical device recalls?

Voluntary recalls are initiated by manufacturers or at FDA’s request under 21 CFR Part 7. Mandatory recalls are required by FDA under specific statutory authority (FD&C Act § 518) when voluntary action is insufficient to protect public health.

How should effectiveness checks be conducted during a medical device recall?

Effectiveness checks verify that recall communications were received, understood, and followed by consignees. They should confirm the recall reached appropriate distribution levels and prompt follow-up actions if customers are non-responsive or instructions weren’t properly executed.

When can a medical device recall be officially terminated?

Recall termination occurs when all possible customer responses are received, recalled products are removed/corrected commensurate with hazard level, final status reports are submitted to FDA, and the Division Recall Coordinator provides formal termination notification.

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What You Need to Do 👇

Recommended Actions

1. Establish internal procedures for recall decision-making and execution
2. Create templates for recall communications and documentation
3. Maintain up-to-date distribution records and customer contact information
4. Develop recall effectiveness check procedures
5. Train relevant personnel on recall procedures and responsibilities
6. Establish communication protocols with FDA Division Recall Coordinator
7. Create procedures for product quarantine, return, and destruction
8. Implement system for tracking recall status and preparing reports
9. Develop procedures for root cause analysis and corrective actions
10. Establish criteria and procedures for recall termination

Key Considerations

Labelling

• Recall communications should be clearly marked as “URGENT: [PRODUCT TYPE] RECALL”
• Include complete product description and identification codes
• Provide clear instructions for product handling and return
• Include product labels in recall communications when helpful for identification

Safety

• Provide detailed health hazard assessment associated with the violation
• Explain how the violation affects product performance and safety
• Include detailed information on complaints and adverse events
• Document root cause analysis and corrective actions

Other considerations

• Submit recall information to FDA as soon as decision is made to recall
• Establish communication with FDA Division Recall Coordinator
• Provide complete distribution information and customer lists
• Conduct effectiveness checks to verify recall communications were received and followed
• Submit monthly recall status reports to FDA
• Maintain proper documentation of product destruction or reconditioning
• Ensure recall reaches appropriate depth in distribution chain
• Obtain FDA concurrence before terminating recall

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Relevant Guidances 🔗

• Distinguishing Between Medical Device Recalls and Device Enhancements
• Public Warning and Notification of Recalls Under Part 7

Related references and norms 📂

• 21 CFR Part 7: Enforcement Policy
• 21 CFR Part 806: Medical Device Reports of Corrections and Removals
• 21 CFR Part 810: Medical Device Recall Authority
• 21 CFR Part 1003: Notification of Defects (Electronic Products)
• 21 CFR Part 1004: Repurchase, Repairs, or Replacement of Electronic Products

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Original guidance

• Product Recalls, Removals, and Corrections: Procedures and Best Practices
• HTML / PDF
• Issue date: 2020-03-02
• Last changed date: 2024-10-01
• Status: FINAL
• Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Biologics, Cosmetics, Recalls
• ReguVirta ID: da06159fab661896a3a54f8992d22266