When is a recall truly complete?
A hospital marks a device recall as closed after distributing instructions to all departments. Yet one affected device remains in storage and has not been checked. Closure governance requires evidence that necessary actions were completed, not merely that notices were sent.
Define closure criteria
The applicable recall notice, clinical risk and institutional procedures determine which actions must be verified.
Reconcile the affected asset list
Compare manufacturer identifiers with inventories and field checks, including mobile or temporarily stored equipment.
Verify technical and clinical actions
Modifications, restrictions, removal or replacement should be completed and confirmed by appropriate personnel.
Resolve outstanding exceptions
Missing devices, unclear serial numbers and incomplete records need documented decisions and ownership.
Communicate final status
Relevant teams should know which devices are safe to use under approved guidance and which remain restricted.
Preserve evidence for audit
Maintain traceable records of affected assets, actions, approvals and verification.
Break-test: a recalled device reappears after closure
Can the hospital identify the control failure and reopen the relevant safety action?
Connected knowledge
See Recall Effectiveness Verification, Recall Execution and HSA.