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

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
30/08/2018 CoaguChek Test Strips for Self-Testing and Point of Care Use. Priority 1 – For Immediate Action. For Immediate Action
29/08/2018 Tautmann UT10 Patient Trolleys. Priority 2 – Warning Warning
23/08/2018 ARCHITECT c4000 Processing Module, ARCHITECT c8000 Processing Module, ARCHITECT c16000 Processing Module Warning
15/08/2018 Dispenser Issues with FLO-LOK III Dispenser. Priority 1 – For Immediate Action For Immediate Action
14/08/2018 BIS™ Vista and BIS™ View Monitoring Systems. Priority 2 - Warning Warning
02/08/2018 Summary of Field Safety Notices - July 2018 3rd Party Publications
02/08/2018 HIV Self-tests - Information Notice Advisory
30/07/2018 Durex Real Feel & Durex Latex Free Condoms. Priority 1 – For Immediate Action For Immediate Action
13/07/2018 Perifix Catheter Connector. Priority 2 – Warning Warning
02/07/2018 Summary of Field Safety Notices - June 2018 3rd Party Publications
02/07/2018 EnTrust® and Escudo® VR/DR/AT ICDs. Priority 1 – For Immediate Action Warning
02/07/2018 Alaris™/ Asena™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps. Priority 2 – Warning Warning
26/06/2018 Philips Ear Thermometer (DL8740) and Philips AVENT Smart Ear Thermometer (SCH740). Priority 2 – Warning Warning
06/06/2018 Covidien Endo GIA™ Articulating Reloads. Priority 2 – Warning Warning
01/06/2018 Summary of Field Safety Notices - May 2018 3rd Party Publications
29/05/2018 Aquilon series of nebulisers - Priority 1 - For Immediate Action For Immediate Action
22/05/2018 IntelliVue MX40 Patient Monitor. Priority 2 – Warning Warning
15/05/2018 Accu-Chek Inform II Accu-Chek Aviva Blood glucose test strips - Risk of incorrect results. Priority 1 – For Immediate Action For Immediate Action
10/05/2018 Opal, Opal Plus, Salisbury and Prime Overlay Mattresses and HH20 Active Seat System. Priority 2 – Warning Warning
04/05/2018 Infinity Acute Care System (IACS) and Standalone Infinity M540 patient monitors Software versions VG2.2 to VG4.1. Priority 2 - Warning Warning