Run Medical Device Recall Response Verification — Free

Inspection Details

Recall notice identifier recorded

Record the recall, safety alert, or field correction identifier exactly as received.

Manufacturer and device family identified

Document the manufacturer name and affected device family/model.

Recall classification captured

Select the recall classification or alert type if provided.

Note (optional)

Recall Intake and Triage

Recall notice received through approved channel critical (required)

Verify the notice was received via the designated compliance, biomed, or vendor management channel.

Yes No N/A

Date and time of receipt documented critical (required)

Capture when the recall notice was first received by the organization.

Initial triage completed and owner assigned critical (required)

Confirm the recall was reviewed, risk assessed, and assigned to a responsible owner for follow-up.

Yes No N/A

Affected locations and departments identified

Select all departments, units, or sites where affected devices may be in service.

Note (optional)

Affected Device Identification

Device model, catalog, or serial range matched to recall notice critical (required)

Verify the facility identified the exact affected model, catalog number, lot, or serial range.

Yes No N/A

Inventory search completed across all known locations critical (required)

Confirm a documented search was performed across storage, point-of-use, loaner, and deployed inventory.

Yes No N/A

Quantity of affected devices identified

Enter the number of affected devices found.

Note (optional)

Unresolved inventory gaps documented critical (required)

Confirm any missing or unverified units were documented and escalated for follow-up.

Yes No N/A

Quarantine and Removal from Service

Affected devices quarantined or removed from service critical (required)

Verify all identified affected devices were physically segregated, tagged, or otherwise removed from clinical use.

Yes No N/A

Quarantine location secured and clearly labeled critical (required)

Confirm the quarantine area prevents inadvertent use and is clearly marked as hold for recall.

Yes No N/A

Device status updated in inventory or CMMS

Verify the asset record reflects recall hold, out-of-service status, or equivalent control.

Yes No N/A

Loaner, rental, or borrowed devices checked for inclusion

Confirm non-owned devices in use were reviewed against the recall scope.

Yes No N/A

Notification, Documentation, and Closure

Clinical and operational stakeholders notified critical (required)

Confirm impacted departments, leadership, and service owners were notified of the recall and required actions.

Yes No N/A

Manufacturer or FDA response instructions documented

Verify any required return, correction, replacement, or reporting instructions were recorded.

Yes No N/A

Closure evidence retained critical (required)

Confirm closure documentation includes search results, quarantine evidence, disposition, and completion status.

Yes No N/A

Inspector signature captured critical (required)

Signature of the person verifying recall response completion.

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Run: Medical Device Recall Response Verification

Inspection Details

Recall Intake and Triage

Affected Device Identification

Quarantine and Removal from Service

Notification, Documentation, and Closure

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