Run Medical Device Recall Response Verification — Free

Recall Notice Intake

Recall notice received from authorized source critical (required)

Confirm the notice came from FDA, the manufacturer, distributor, or internal safety/compliance channel and includes the recall identifier.

Yes No N/A

Recall notice logged with date and time received critical (required)

Record the date/time the notice was received and entered into the recall tracking log or case management system.

Note (optional)

Recall classification documented

Capture the recall type or classification if provided (for example, correction, removal, or field action) and the reason for the recall.

Recall owner assigned critical (required)

Identify the responsible person or department for coordinating response actions, communications, and closure.

Affected sites or departments notified critical (required)

Verify the recall alert was communicated to all relevant clinical areas, storage locations, and service teams.

Yes No N/A

Affected Device Identification

Device model and catalog number matched to recall notice critical (required)

Verify the device model, catalog number, or UDI matches the recalled product description.

Serial numbers or lot numbers identified critical (required)

Document all affected serial numbers, lot numbers, or batch identifiers found in inventory, clinical use, or service records.

Note (optional)

Affected device count verified critical (required)

Enter the number of affected devices identified across inventory, patient care areas, loaners, and service stock.

Note (optional)

Current device locations documented critical (required)

Record where each affected device was found, including department, storage area, or offsite location if applicable.

No additional affected devices remain unaccounted for critical (required)

Confirm reconciliation is complete and there are no known unreconciled affected devices remaining in circulation.

Yes No N/A

Quarantine and Removal Actions

Affected devices removed from clinical use critical (required)

Confirm all identified affected devices were taken out of service and are not available for patient care.

Yes No N/A

Quarantine area secured and labeled critical (required)

Verify quarantined devices are physically segregated, clearly labeled, and protected from accidental use or redistribution.

Yes No N/A

Removal or return instructions followed critical (required)

Confirm the facility followed manufacturer or FDA-directed instructions for return, disposal, correction, or replacement.

Yes No N/A

Quarantine inventory count reconciled critical (required)

Verify the number of devices in quarantine matches the identified affected count and any discrepancies are explained.

Note (optional)

Temporary controls implemented for patient safety

Document any interim controls such as replacement devices, alternate workflows, or use restrictions until the recall is closed.

Communication and Escalation

Clinical leadership notified critical (required)

Verify the recall was communicated to nursing, physicians, department leadership, or other affected clinical owners.

Yes No N/A

Biomed, supply chain, and quality/compliance notified critical (required)

Confirm the teams responsible for inventory control, service, and compliance oversight were informed.

Yes No N/A

Escalation to FDA, manufacturer, or AHJ completed when required

Document whether any reportable event, serious injury, malfunction, or other escalation was made to the appropriate external party or Authority Having Jurisdiction.

Yes No N/A

Note (optional)

Patient notification required and completed

If the recall required patient notification, confirm the notification process was completed and tracked.

Yes No N/A

Communication log retained critical (required)

Verify emails, call logs, memos, or system notifications are retained in the recall record.

Yes No N/A

Closure Documentation

Disposition documented for each affected device critical (required)

Record whether each device was returned, repaired, replaced, destroyed, or otherwise resolved.

Corrective actions documented

Summarize any process changes, training, inventory controls, or preventive actions implemented to prevent recurrence.

Closure review completed by responsible leader critical (required)

Confirm the recall response was reviewed and approved for closure by the designated owner or manager.

Note (optional)

Supporting records attached critical (required)

Attach the recall notice, device reconciliation list, quarantine evidence, communications, and closure summary.

Yes No N/A

Note (optional)

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Run: Medical Device Recall Response Verification

Recall Notice Intake

Affected Device Identification

Quarantine and Removal Actions

Communication and Escalation

Closure Documentation

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