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
02/12/2010 Field Safety Notice Monthly Summary Sheet - November 2010 3rd Party Publications
05/11/2010 Field Safety Notice Monthly Summary Sheet - October 2010 3rd Party Publications
01/11/2010 Single Use & Single Patient Use Medical Devices Advisory
07/10/2010 Field Safety Notice Monthly Summary Sheet - September 2010 3rd Party Publications
05/10/2010 Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers) 05.10.2010 Advisory
30/09/2010 Stryker Model 6100 M1 Ambulance Cot Advisory
16/09/2010 Cleaning and Decontamination of Reusable Medical Devices Advisory
03/09/2010 Field Safety Notice Monthly Summary Sheet - August 2010 3rd Party Publications
27/08/2010 ASR™ Articular Surface Replacement and ASR™ XL Acetabular System Advisory
13/08/2010 Effective Traceability of Medical Devices Advisory
06/08/2010 Field Safety Notice Monthly Summary Sheet - July 2010 3rd Party Publications
19/07/2010 LIFEPAK® CR Plus Automatic External Defibrillator Advisory
16/07/2010 Counterfeit PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set Warning
05/07/2010 Field Safety Notice Monthly Summary Sheet - June 2010 3rd Party Publications
14/06/2010 Intracranial Stent SILK Advisory
10/06/2010 Hospital Beds / Cots Advisory
03/06/2010 Field Safety Notice Monthly Summary Sheet - May 2010 3rd Party Publications
17/05/2010 M Series Heated Humidifier Advisory
12/05/2010 Field Safety Notice Monthly Summary Sheet - April 2010 3rd Party Publications
10/05/2010 Apheresis Systems Advisory