Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at



HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.


Date Title Type
04/09/2018 Field Safety Notice – August 2018 3rd Party Publications
30/08/2018 CoaguChek Test Strips for Self-Testing and Point of Care Use. Priority 1 – For Immediate Action. For Immediate Action
29/08/2018 Tautmann UT10 Patient Trolleys. Priority 2 – Warning Warning
23/08/2018 ARCHITECT c4000 Processing Module, ARCHITECT c8000 Processing Module, ARCHITECT c16000 Processing Module Warning
15/08/2018 Dispenser Issues with FLO-LOK III Dispenser. Priority 1 – For Immediate Action For Immediate Action
14/08/2018 BIS™ Vista and BIS™ View Monitoring Systems. Priority 2 - Warning Warning
02/08/2018 Summary of Field Safety Notices - July 2018 3rd Party Publications
02/08/2018 HIV Self-tests - Information Notice Advisory
30/07/2018 Durex Real Feel & Durex Latex Free Condoms. Priority 1 – For Immediate Action For Immediate Action
13/07/2018 Perifix Catheter Connector. Priority 2 – Warning Warning
02/07/2018 Summary of Field Safety Notices - June 2018 3rd Party Publications
02/07/2018 EnTrust® and Escudo® VR/DR/AT ICDs. Priority 1 – For Immediate Action Warning
02/07/2018 Alaris™/ Asena™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps. Priority 2 – Warning Warning
26/06/2018 Philips Ear Thermometer (DL8740) and Philips AVENT Smart Ear Thermometer (SCH740). Priority 2 – Warning Warning
06/06/2018 Covidien Endo GIA™ Articulating Reloads. Priority 2 – Warning Warning
01/06/2018 Summary of Field Safety Notices - May 2018 3rd Party Publications
29/05/2018 Aquilon series of nebulisers - Priority 1 - For Immediate Action For Immediate Action
22/05/2018 IntelliVue MX40 Patient Monitor. Priority 2 – Warning Warning
15/05/2018 Accu-Chek Inform II Accu-Chek Aviva Blood glucose test strips - Risk of incorrect results. Priority 1 – For Immediate Action For Immediate Action
10/05/2018 Opal, Opal Plus, Salisbury and Prime Overlay Mattresses and HH20 Active Seat System. Priority 2 – Warning Warning