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
02/09/2020 Summary of Field Safety Notices - August 2020 3rd Party Publications
02/09/2020 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
26/08/2020 Covidien Endo GIA™ Auto Suture™ universal articulating loading units, Priority 1 – For Immediate Action For Immediate Action
19/08/2020 Datascope/Getinge/Maquet Intra-Aortic Balloon Catheters: Priority 2 – Warning Warning
13/08/2020 TOP-Q Super Fine Line, TOP-Q Super Derm Line, TOP-Q Super Deep Line. Priority 2 – Warning Warning
10/08/2020 Lifepak 500 Automated External Defibrillator. Priority 2 – Warning Warning
05/08/2020 Summary of Field Safety Notices - July 2020 3rd Party Publications
22/07/2020 COVID-19 testing in Ireland by commercial entities outside the National Testing Strategy Advisory
02/07/2020 Summary of Field Safety Notices - June 2020 3rd Party Publications
24/06/2020 Lifeguard LG20, LG50, LG55. Priority 2 - Warning Advisory
17/06/2020 ACTIV.A.C.™ Therapy Units. Priority 2 – Warning Advisory
11/06/2020 Philips HeartStart XL Defibrillator/Monitor. Priority 2 – Warning Warning
11/06/2020 Risk of harmful reactions in laboratories using certain chemicals in combination with bleach. Priority 2 – Warning Warning
08/06/2020 Caution When Purchasing Thermometers Advisory
03/06/2020 Summary of Field Safety Notices - May 2020 3rd Party Publications
05/05/2020 Summary of Field Safety Notices - April 2020 3rd Party Publications
02/04/2020 Summary of Field Safety Notices - March 2020 3rd Party Publications
01/04/2020 MAGEC Spinal Bracing and Distraction System. Priority 2 – Warning Warning
27/03/2020 Falsified diagnostic tests for Covid-19 (SARS-CoV-2) Advisory
13/03/2020 Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy Advisory