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
02/04/2009 Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S Advisory
05/09/2008 Blood Component Bags and Transfusion Giving Sets Warning
29/07/2008 Safe and Effective Use of Bench-top Steam Sterilisers 29.07.2008 Advisory
10/06/2008 Disposable Infusion Devices Advisory
15/04/2008 Clinitest® hCG Cassette Pregnancy Test Kit Recall
02/04/2008 Coopers Walking Frames Advisory
01/02/2008 Baby Beets Fetal Doppler Warning
31/01/2008 H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory Warning
24/01/2008 IntraStent Unmounted Balloon Expandable Stent Recall
17/10/2007 Medical Devices Recommended by Healthcare Institutions for Use in a Community Setting Advisory
15/10/2007 Recall of Medtronic Sprint Fidelis Defibrillation Leads Recall
27/07/2007 EVAQUA Breathing Circuits Warning
27/07/2007 Scholl Freeze Verruca and Wart Remover Warning
27/07/2007 Mini Lift Stand Aid Warning
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