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
12/06/2007 Clearview HCG Pregnancy Test Kit Recall
10/05/2007 Shelhigh Implantable Devices Recall
20/11/2006 K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs Warning
29/09/2006 Diagnostic Kits for Self-Testing Warning
05/09/2006 Avantgarde Wheelchair Warning
21/06/2006 Scooter Sungift 500 Recall
20/06/2006 Reusable Needle Holders / Blood Tube Holders Advisory
01/06/2006 The Procurement and Commissioning of Medical Equipment for Hospitals Advisory
21/04/2006 Bausch and Lomb ReNu with MoistureLoc Multi-Purpose Solution 3rd Party Publications
14/03/2006 Profile Respiratory System CR60 and Porta-Neb Advisory
12/01/2006 Hospital Beds in Paediatric Wards Advisory
12/12/2005 Cardio Respiratory Monitors Advisory
26/10/2005 Illegally CE Marked Medical Devices Advisory
09/06/2005 'Tulip' Condoms Advisory
14/03/2005 Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms Recall
15/11/2004 AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices Recall
14/10/2004 Sterile Devices Advisory
20/09/2004 Invasive Blood Pressure Monitoring Devices with Transducers Advisory
13/08/2004 Haemodialysis Equipment Advisory
13/08/2004 Instructions for Use provided by the Medical Device Manufacturer Advisory