Run Medical Device Recall Response Verification — Free

Recall Notice Intake

Recall notice received and logged critical (required)

Confirm the recall notice was received, date/time stamped, and entered into the tracking log or ticketing system.

Source of recall notice identified critical (required)

Record the source of the notice, such as FDA, manufacturer, distributor, or internal safety team.

Note (optional)

Recall identifier recorded critical (required)

Capture the recall number, alert number, lot number, serial number range, or other manufacturer reference used to identify the action.

Affected device model and UDI identified critical (required)

Verify the device model, catalog number, and UDI or equivalent identifier are documented for the recall.

Recall classification and urgency reviewed

Document whether the recall is urgent, high risk, or routine, and whether immediate action is required.

Note (optional)

Affected Device Identification

Inventory search completed for affected devices critical (required)

Confirm a search was performed across inventory, storage, in-use locations, loaners, and offsite areas for all affected devices.

Yes No N/A

In-service devices identified critical (required)

Record the number of affected devices currently in service or available for patient use.

Note (optional)

Devices in inventory identified critical (required)

Record the number of affected devices located in storage, receiving, or spare inventory.

Note (optional)

Serial numbers or lot numbers matched to recall scope critical (required)

Verify each located device was matched against the recall scope using serial number, lot number, or other applicable identifier.

Yes No N/A

Unresolved device count documented

Record any affected devices that could not be located or verified and explain the gap.

Note (optional)

Quarantine and Removal Actions

Affected devices removed from service critical (required)

Verify all identified affected devices were taken out of clinical use or removed from availability.

Yes No N/A

Quarantine area established and labeled critical (required)

Confirm quarantined devices are segregated, clearly labeled, and protected from accidental use.

Yes No N/A

Quarantine date and responsible person recorded critical (required)

Document when quarantine occurred and who completed the action.

Note (optional)

Manufacturer return, repair, or disposal instructions reviewed critical (required)

Verify the recall instructions for return, repair, replacement, or disposal were reviewed and followed.

Yes No N/A

Patient care impact assessed

Document whether the recall created any interruption to patient care, replacement need, or temporary workaround.

Note (optional)

Notifications and Escalation

Clinical leadership notified critical (required)

Confirm the appropriate clinical manager, department leader, or service line owner was notified.

Yes No N/A

Risk management or compliance notified

Confirm risk management, compliance, or quality leadership was notified when required by policy.

Yes No N/A

Manufacturer or distributor contacted for disposition guidance

Document whether follow-up contact was made to clarify return, replacement, or disposition requirements.

Yes No N/A

Escalation required for unresolved devices

Indicate whether unresolved devices were escalated to leadership for further search or containment.

Yes No N/A

Escalation notes

Provide a concise summary of any escalations, including who was notified and what action was requested.

Closure Documentation

Recall response summary completed critical (required)

Confirm the final response summary includes devices identified, devices quarantined, and disposition status.

Yes No N/A

Supporting records attached critical (required)

Verify supporting evidence is attached, such as recall notice, inventory list, quarantine log, and correspondence.

Yes No N/A

Closure date recorded critical (required)

Document the date the recall response was closed or submitted for final review.

Note (optional)

Open actions remain critical (required)

Indicate whether any open actions remain after closure review.

Yes No N/A

Final reviewer signature critical (required)

Signature of the person approving the recall response verification.

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Run: Medical Device Recall Response Verification

Recall Notice Intake

Affected Device Identification

Quarantine and Removal Actions

Notifications and Escalation

Closure Documentation

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