Your Device Was Recalled — Did You Know?
Published 28 March 2026 · 9 min read
How the Real-World Chain Works
Picture this: five years ago, a company sold an infusion pump to your hospital. The sale went through clinical engineering, or procurement, or finance — whoever signed the purchase order at the time. That person became the company's contact in their records.
Fast-forward to today. A safety alert is issued for that pump. The manufacturer sends a Field Safety Notice to the email address they have on file — the person who handled the original purchase. If that person is on leave, the email sits until they return. If they've changed role or left the organisation, it may take longer still to reach the right desk. When it does arrive, it gets logged, and the question becomes: how quickly does that information reach the nurse on the ward who connects that pump to a patient every morning?
This is the real-world communication chain that MDR 2017/745 is designed to strengthen. It is not about blaming anyone — hospitals have always worked to keep patients safe. It is about building more robust, structured processes so that safety-critical information reaches frontline staff reliably and promptly, regardless of who originally bought the device or whether they are available on any given day.
The good news:
Irish hospitals are already moving in the right direction. The Department of Quality and Patient Safety (QPS) is actively working to establish best practice in this area, and many hospitals have significantly improved their FSN communication processes in recent years. The MDR provides the regulatory framework to support and accelerate what the health service is already striving to achieve.
What Is a Field Safety Notice?
When a manufacturer identifies a safety issue with a medical device that is already on the market, they must take a Field Safety Corrective Action (FSCA). This might mean recalling the device, issuing updated instructions, modifying the device, or advising healthcare professionals on mitigation measures.
The communication that accompanies an FSCA is called a Field Safety Notice (FSN). It is the manufacturer's formal notification to healthcare professionals about the safety issue and what action to take.
Under MDR Article 89, manufacturers must report FSCAs to the relevant competent authority — in Ireland, that's the HPRA. The HPRA publishes these on their safety notices database, and manufacturers send FSNs directly to affected healthcare institutions.
Where Delays Can Happen
The regulatory framework requires that FSNs are acted upon once they reach a hospital. But the regulation does not prescribe exactly how a hospital should manage that internal process — and in a busy healthcare environment, there are practical challenges that every hospital is working to address.
Challenges hospitals are actively working on:
- Manufacturer contact records may be outdated — the person who signed the original purchase order may have moved on or be unavailable
- FSNs arriving to a single contact point can be delayed if that individual is on leave or absent
- Procurement and clinical engineering may reference the same device by different names or catalogue numbers
- Devices spread across multiple wards make it harder to identify all affected units quickly
- Agency or temporary nursing staff may not be captured by the standard internal communication channels
- Shift patterns mean that not all staff receive information at the same time
These are not failures of intent — they are practical realities of complex healthcare organisations. The important thing is that hospitals are recognising these challenges and continuously building better systems to ensure safety information reaches every person who needs it, as quickly as possible.
What MDR Article 14 Actually Says
MDR Article 14 sets out the obligations of health institutions. While much of the MDR focuses on manufacturers and economic operators, Article 14 places specific duties on hospitals:
- Cooperate with manufacturers on Field Safety Corrective Actions (Article 14(1))
- Report incidents to the competent authority (HPRA) when a device causes or could cause a serious incident (Article 14(2))
- Store and maintain devices in accordance with the manufacturer's instructions (Article 14(3))
- Maintain UDI records for implantable devices (Article 14(5))
The obligation to “cooperate with manufacturers” on FSCAs means that hospitals cannot simply receive an FSN and file it away. There must be a documented process that ensures the corrective action is actually carried out — whether that means quarantining stock, returning devices, updating procedures, or informing staff.
What a Practical FSN Process Looks Like
Hospitals that manage this well typically have a documented procedure with clear responsibilities:
- Single point of receipt: All FSNs go to a designated coordinator (usually in clinical engineering or quality/risk)
- Affected device identification: Cross-reference against the asset register or procurement records to identify every unit in the hospital
- Ward-level notification: Direct communication to the CNM/ward manager of every affected area — not just an email, but a documented acknowledgement
- Action tracking: Log what action was taken, when, and by whom. Track completion.
- Manufacturer response: Confirm back to the manufacturer that the FSCA has been implemented
- Closure: Document the resolution and retain the record
The critical step is number 3 — ward-level notification. Many hospitals have made significant progress here, moving from informal email forwarding to structured acknowledgement processes. The goal is straightforward: an FSN should reach the people who use the device, not just the people who bought it.
What You Can Do Right Now
As a ward nurse or clinical staff member:
- Ask your line manager: “How would I find out if a device I use daily has been recalled?”
- Check the HPRA safety notices database periodically for devices in your area
- If you find you're using a device with an active FSN — report it through your local incident reporting system
As a clinical engineer or quality manager:
- Audit your FSN process — can you demonstrate that ward staff were notified for the last 5 FSCAs?
- Build FSN acknowledgement into your electronic quality management system
- Include FSN communication in new staff induction and agency nurse briefing packs
Related Training
This topic is covered in depth across two of our training modules: