Safety Notices

HPRA Safety Notice Communication

We publish notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

View the current safety notices for medical devices below.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to

Learn more about HPRA safety notices.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices.

Date Title Type
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 LIFEPAKĀ® 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
15/04/2010 ARCHITECT Anti-HCV Reagents Advisory
01/04/2010 Field Safety Notice Monthly Summary Sheet - March 2010 3rd Party Publications
02/03/2010 Field Safety Notice Monthly Summary Sheet - February 2010 3rd Party Publications
18/02/2010 Wallach LL100 Cryosurgical System CO2 and Accessories Advisory
15/02/2010 Publication of Field Safety Notices 3rd Party Publications
04/01/2010 Field Safety Notice Monthly Summary Sheet - January 2010 3rd Party Publications
10/12/2009 Zoll AED Plus Defibrillator 10.12.2009 Advisory
10/12/2009 Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator Advisory
01/12/2009 Field Safety Notice Monthly Summary Sheet - December 2009 3rd Party Publications