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 devicesafety@hpra.ie.

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
27/08/2010 ASR™ Articular Surface Replacement and ASR™ XL Acetabular System Advisory
13/08/2010 Effective Traceability of Medical Devices Advisory
19/07/2010 LIFEPAK® CR Plus Automatic External Defibrillator Advisory
14/06/2010 Intracranial Stent SILK Advisory
10/06/2010 Hospital Beds / Cots Advisory
17/05/2010 M Series Heated Humidifier Advisory
10/05/2010 Apheresis Systems Advisory
15/04/2010 ARCHITECT Anti-HCV Reagents Advisory
18/02/2010 Wallach LL100 Cryosurgical System CO2 and Accessories Advisory
10/12/2009 Zoll AED Plus Defibrillator 10.12.2009 Advisory
10/12/2009 Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator Advisory
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
21/08/2009 Contoura 880 Beds Advisory
27/04/2009 Safe and Effective Use of Bench-top Steam Sterilisers Advisory
02/04/2009 Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S Advisory
29/07/2008 Safe and Effective Use of Bench-top Steam Sterilisers 29.07.2008 Advisory
10/06/2008 Disposable Infusion Devices Advisory
02/04/2008 Coopers Walking Frames Advisory