Remedial Action - Recall Procedure | ISO 13485 | FDA QMSR

The Remedial Action / Recall Procedure establishes the process for implementing remedial action for nonconforming medical device product. The Remedial Action / Recall procedure applies to all medical device products marketed domestically and internationally.

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Remedial Action | Recall Procedure

The Remedial Action / Recall Procedure establishes the procedure for implementing remedial action for nonconforming product. The Remedial Action / Recall Procedure applies to all products marketed in the United States and internationally.

Remedial Action / Recall Procedure - Overview

The Remedial Action / Recall Procedure includes detailed instruction on conducting remedial action investigations, development of a remedial action plan, product corrections, communication method, implementation and effectiveness checks, status reports, and close out and termination of remedial action / recall. The Remedial Action / Recall Procedure includes a remedial action plan document, sample consignee letter, consignee reply form, sample recall effectiveness check form and a tracking recall spreadsheet.

Regulatory framework

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.