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
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
05/11/2009 K-Tips - Important Safety Information from Roche Diagnostics GmbH 3rd Party Publications
02/11/2009 Field Safety Notice Monthly Summary Sheet - November 2009 3rd Party Publications
28/10/2009 Lifting Equipment Advisory
28/10/2009 Wheelchairs used in Vehicles Advisory
23/10/2009 All Posture / Safety Belts fitted to Hoists, Seating, Stair Lifts, Buggies and Wheelchairs Advisory
23/10/2009 Blood Glucose Meters and Test Strips 23.10.2009 Warning
01/10/2009 Field Safety Notice Monthly Summary Sheet - October 2009 3rd Party Publications
01/09/2009 Field Safety Notice Monthly Summary Sheet - September 2009 3rd Party Publications
21/08/2009 Contoura 880 Beds Advisory
14/08/2009 LeVeen Needle Electrodes – 5.0cm - Important Safety Information from Boston Scientific 3rd Party Publications