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RECALL MANAGEMENT

Recall Management Software for Medical Devices

Smarteeva's Recall Management system puts the entire recall lifecycle in one platform - the recall decision, notification creation and approval, distribution to customers and distributors, acknowledgement tracking, follow-up, and closure with a complete audit trail.

  • Notification generation with built-in approval workflows‍
  • A dedicated portal for customers, affiliates and distributors
  • Lot-level distribution and acknowledgement tracking‍
  • Effectiveness checks tracked and evidenced in the recall file
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Trusted by 450+ MedTech companies of every size
Dashboard showing email status with 80% opened and a bar chart for contact completion codes.
The Problem

When a recall is declared, the clock starts. Most teams aren't ready.

Notifications built one at a time

No template system means every notification is written by hand, reviewed individually, and sent through disconnected channels. The same recall goes out three different ways depending on who prepared it.

Follow-up tracked in spreadsheets

Response rates are compiled manually. Nobody has a current view of who acknowledged, who acted, and who has not replied.

Regulators ask, you assemble

"Can you demonstrate that every affected customer was notified and responded?" Without one system holding the record, answering that takes days of reconstruction.
Automated Recall Management

How automated Recall Management works

Manual recall handling breaks at the same three points every time: creating notifications, getting them to the right recipients, and proving who responded. An automated recall management system closes all three in one record.

Read blog

Decision and scope

The recall record is created and linked to the affected product, lot numbers and distribution history already held in the platform. Scope comes from your own data rather than from a separately maintained list.

 Notification generation and approval

Quality notices, safety alerts, field corrections and full product recall notifications are created from configurable templates. Built-in approval workflows route each one for review and authorisation before anything leaves the building.

Distribution to the right recipients

Notifications are distributed to customers, affiliates, distributors and field service teams through Smarteeva's cloud distribution. Distribution lists are held in the platform, so coverage is derived from your records rather than rebuilt for each event.

Acknowledgement, follow-up and escalation

Recipients respond through a dedicated portal. Acknowledgements, actions taken and follow-up information are captured against the original record instead of arriving as email replies that somebody has to collate. Automated reminders go to recipients who have not responded, and the system alerts your team when follow-up is overdue.

Effectiveness checks

Notifying is not the same as resolving. Effectiveness checks are tracked against the recall record, so the question of whether the recall achieved what it set out to achieve is answered with evidence rather than an assertion.

Closure with the file already assembled

Every action is logged as it happens: when notifications were created, who approved them, when they were distributed, who received them, who acknowledged them, what actions were taken, and how effectiveness was verified. The recall file is complete at closure rather than reconstructed afterwards.

What Smarteeva handles,
end to end.

From the first notification to confirmed closure, every step is managed in one place.

Why us?

Recall Notification Generation & Approval

Create quality notices, safety alerts, field corrections and full product recall notifications inside Smarteeva. Approval workflows route every notification for review and authorisation before distribution. Templates speed up creation while maintaining consistent regulatory language and formatting.

Lot-Level Distribution

Distribute notifications to customers, affiliates, distributors and field service teams through Smarteeva's cloud distribution. Notifications are matched to the lots actually distributed rather than issued to an entire customer list, and manufacturer and distributor notices are deduplicated so recipients receive one notification rather than three. Distribution lists are managed in the platform, so coverage comes from the records you already maintain.

Recall Management Portal

The portal gives customers, affiliates and distributors a dedicated interface to view recall notifications, acknowledge receipt, report actions taken and submit follow-up information. Responses land directly against the recall record.

Follow-Up Tracking

Follow-up forms and automated reminders track every recipient through to resolution. Smarteeva monitors acknowledgement rates, tracks corrective actions at customer level, and alerts your team when follow-up is overdue.

Effectiveness checks

FDA expects manufacturers to demonstrate that a recall worked, not to state that it did. Effectiveness checks are tracked against the recall record alongside the acknowledgements and corrective actions they relate to. The evidence sits in the same file as the notification that started it.

Complete audit trail

Every action in the recall lifecycle is logged with timestamps and user attribution. Colour-coded change tracking shows what changed, when, by whom and why, across every related record.
MedTech Recalls gateway

THE Hospital and Distributor side

Recalls fail at the receiving end, not the sending end.

Smarteeva's primary research with healthcare providers identified six structural failures in recall communication between manufacturers and hospitals: volume overload, generic notices, duplicate notifications, missing context in follow-ups, misrouted notices, and reconciliation delays.

A notification that reaches the wrong department in a hospital has not reached anyone. Most recall software stops measuring at the point of sending.

Smarteeva routes notifications to the right function inside the receiving organisation, whether that sits in Supply Chain, Materials Management or Quality. Reconciliation between hospitals and manufacturers runs inside the platform rather than over email.
MedTech Recalls Gateway is Smarteeva's recall tracking and management resource for the provider side of that exchange.

Explore MedTech Recalls Gateway
Read the blog

Regulatory context

The regulatory frameworks for recalls sit inside. Recall obligations differ by market, and a manufacturer selling into both the United States and Europe answers to both.

United States

FDA classifies recalls by the health risk the product presents, from Class I where use could cause serious injury or death, through to Class III. Corrections and removals reporting falls under 21 CFR Part 806, and FDA expects manufacturers to provide evidence of the reach and effectiveness of a recall rather than assert it.

European Union

EU Medical Device Regulation 2017/745 requires manufacturers to report field safety corrective actions and to issue Field Safety Notices to affected users. Reporting runs through the competent authority in each Member State.

What both share

Every framework asks the same underlying question: can you demonstrate who was notified, who responded, and what they did. That question is a records problem before it is a regulatory one.
CHOOSING RECALL MANAGEMENT SOFTWARE

What to look for in recall management software

Does it hold distribution data, or ask you for it?
If you have to supply a recipient list at the point of recall, the system uses a mail merge. Distribution scope should come from records the platform already holds.
 Can it match to lot level?
Recalling a product line when three lots are affected costs customer trust and creates avoidable work at the receiving end.
Does it deduplicate?
Customers who receive the same notice from a manufacturer and a distributor stop reading it.
Does it track responses, or just sends?
Acknowledgement rate is the number a regulator asks about. Delivery rate is not the same thing.
Does it handle effectiveness checks?
This is the question most recall software cannot answer. Notifying every affected customer is the start of a recall, and demonstrating that the recall achieved its purpose is the end of one.
Does it connect to complaint data?
Recalls usually start as complaint signals. If the two systems are separate, the link between them is manual.

Questions?

We’re glad you asked.

What is recall management software?

Recall management software runs the recall lifecycle for a manufacturer: deciding scope, creating and approving notifications, distributing them to affected customers and distributors, tracking acknowledgements and corrective actions, and holding the audit record through to closure.

Does Smarteeva support recall effectiveness checks?

Yes. Effectiveness checks are tracked against the recall record, so the evidence that a recall achieved its purpose sits in the same file as the notifications, acknowledgements and corrective actions it relates to.

How does Smarteeva track who has responded?

Yes. Smarteeva generates the report and does the data assembly. Your regulatory team reviews the output, adds expert commentary, ensures conclusions are accurate, and submits. The AI handles the labor; your team provides the judgment. Acknowledgements and actions are recorded against the recall record as they arrive. Automated reminders go to recipients who have not responded, and the system alerts your team when follow-up is overdue.

What types of notices does Smarteeva Recall Management support?

Quality notices, safety alerts, field corrections, service notices and full product recall notifications, all with configurable templates, approval workflows and distribution tracking.

Does Smarteeva work for hospitals and distributors as well as manufacturers?

The recall management portal is built for the receiving side. MedTech Recalls Gateway is Smarteeva's recall tracking resource for healthcare providers.

How is the recall audit trail maintained?

Every action is logged with a timestamp and user attribution as it happens, across notifications, approvals, distributions, acknowledgements and corrective actions.

1 in 5 FDA recalls is already managed here

See the full lifecycle in 30 minutes, from notification through to effectiveness checks, configured for your device types and distribution markets.

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Trusted by leading enterprise companies around the world
Trusted by 450+ MedTech companies across 80+ countries