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
03/11/2015 Summary of Field Safety Notices - October 2015 3rd Party Publications
20/10/2015 Liko Bathing Chair. Priority 2 – Warning Warning
20/10/2015 Ceiling Mounted Rail Systems for all Liko Stationary Lifts - Likorall, Multirall and Masterlift. Priority 2 – Warning Warning
19/10/2015 Coloplast Testicular Implant and Vaginal Stent. Priority 1 – For Immediate Action For Immediate Action
02/10/2015 Sterile Water for Irrigation 1000ml & 0.9% Sodium Chloride for Irrigation. Priority 1 – For Immediate Action For Immediate Action
02/10/2015 Summary of Field Safety Notice – September 2015 3rd Party Publications
30/09/2015 Silimed Implants. Priority 1 – For Immediate Action For Immediate Action
01/09/2015 Summary of Field Safety Notices - August 2015 3rd Party Publications
24/08/2015 SURE-T, SURE-T Paradigm, Contact Detach, Contact, Sub Q, Neria, Neria Detach, Neria Multi, Thalaset. Priority 2 – Warning Warning
14/08/2015 Compatibility Of Consumable Devices With Heater Coolers. Priority 2 – Warning Warning
13/08/2015 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative. Priority 2 – Warning Warning
06/08/2015 Philips HeartStart XL+ Defibrillator/Monitor. Priority 2 – Warning Warning
05/08/2015 Summary of Field Safety Notice – July 2015 3rd Party Publications
04/08/2015 Animas Vibe Insulin Infusion Pump. Priority 2 – Warning Warning
17/07/2015 SureFlex™ Reusable Fibers and Reusable Stripper and Cleaver Accessories. Priority 1 – For Immediate Action For Immediate Action
15/07/2015 Sterile Forceps. Priority 1 – For Immediate Action For Immediate Action
07/07/2015 SOMNOventCR and prismaCR. Priority 2 – Warning Warning
02/07/2015 Summary of Field Safety Notices - June 2015 3rd Party Publications
18/06/2015 CRIT-LINE® Blood Chamber. Priority 2 – Warning Warning
12/06/2015 Derma C - Priority 2 – Warning Warning