Remedial Action - Recall Procedure | ISO 13485 | FDA QMSR

Plan and document medical device recalls and field corrections with this editable Remedial Action / Recall Procedure and forms. It covers health-hazard assessment, affected lots and distribution, action plans, consignee communication, response tracking, effectiveness checks and closure.

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Supplied as three editable Microsoft Word documents (the procedure and two forms) in a digital download.

Investigations and records

It covers investigations, remedial action plans, product corrections, communication, implementation, effectiveness checks, status reports, and closure or termination. Included records are a remedial action plan, sample consignee letter, consignee reply form, sample recall effectiveness check form and recall tracking spreadsheet.

The remedial-action procedure moves from a failure investigation and health-hazard assessment to a written action plan. The team defines affected products and lots, distribution history, the proposed field action, customer and agency communications, response tracking and effectiveness checks. It then follows status reporting and close-out records. This gives quality and regulatory personnel a coordinated way to plan, execute and document a recall or other field correction.

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

For evaluating serious incidents and field safety corrective actions, see the Vigilance Procedure.

To identify and segregate suspect product while a field action is assessed, see the Product Hold Procedure. For a separate product failure root-cause workflow, see the separately sold Failure Investigation Procedure. The hold and recall procedures are included in the Complaint Handling Procedures Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read FDA MDR, EU Vigilance and Medical Device Recall Workflows for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Complaint Handling Procedures Bundle. Explore the bundle for the related documents.