Closing the Recall Execution Gap: A Governance Framework for Verified Medical Device Recall Completion in Global Health Systems

Background: Medical devices circulate through complex, multilateral supply chains, and products subject to safety recalls in one jurisdiction may remain in clinical use in others. High-severity recalls are typically managed through the issuance of safety notices and specification of corrective actions. However, these measures do not confirm whether corrective actions have been completed for every affected device in clinical use. This problem is particularly acute in health systems with limited digital infrastructure, fragmented supply chains, or weak installed-base visibility. This study proposes a governance framework for verified medical device recall completion that is applicable across diverse health system settings, including resource-constrained environments. Results: We define the recall execution gap as the discrepancy between issuance of a recall notice and demonstrable, unit-level completion of corrective actions at the point of care. To address this gap, we propose two linked components. The Recall Closure Evidence Set (RCES) specifies the minimum auditable evidence required to verify that each affected unit has been identified, acted upon, and verified or managed as an exception, with implementation guidance adapted for lower-resource settings. The Recall Oversight Quality (ROQ) maturity model describes five progressive levels of organisational capability, with equity of closure embedded as a governance expectation from Level 3 onwards. A compact metric suite is also proposed, including time-to-identification, time-to-action, verified closure rate, exception burden, residual risk duration, and equity of closure, with indicative threshold guidance. The methodological advance of this framework lies in the formal specification of minimum auditable closure evidence and staged recall-governance capability in a form applicable across both high-capacity and lower-capacity health systems. Conclusions: Reframing recall closure as a patient-safety intervention rather than an administrative endpoint strengthens post-market surveillance by shifting attention from notification to verified risk mitigation. Because the framework relies on routine operational artefacts rather than advanced digital platforms, it offers a feasible pathway for staged improvement in lower-capacity settings. Prospective validation across diverse health system contexts is a priority for future research.