A health systems governance framework for verifying medical device recall completion

Abstract Background Medical device recalls are commonly managed through notices and specified corrective actions, but these steps do not by themselves verify that every affected device in clinical use has been identified, acted on, and closed. This creates a recall execution gap that is especially difficult to manage in organisations with fragmented inventories, limited installed-base visibility, or weaker digital infrastructure. Methods This conceptual framework paper constructed an implementation-oriented governance framework through structured synthesis of regulatory guidance, post-market surveillance expectations, quality-management principles, and health systems implementation literature, with illustrative application to publicly available recall records and a constructed cross-border scenario. Results The proposed framework comprises three linked components. First, the Recall Closure Evidence Set (RCES) defines the minimum auditable evidence needed to verify unit-level recall completion or documented exception handling. Second, the Recall Oversight Quality (ROQ) maturity model describes five progressive levels of organisational recall-governance capability. Third, a compact metric suite operationalises monitoring through time-to-identification, time-to-action, verified closure rate, exception burden, residual risk duration, and equity of closure. The contribution is a practical governance specification that can be implemented using routine operational artefacts rather than advanced digital platforms. Conclusions Reframing recall closure as a measurable patient-safety process shifts oversight from notice issuance to verified risk mitigation. The proposed framework offers a feasible staged pathway for hospitals and health systems, including lower-capacity settings. Prospective validation in real-world service environments is needed.