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
05/05/2020 Summary of Field Safety Notices - April 2020 3rd Party Publications
01/05/2020 Field Safety Notice Summary Sheet - Outstanding Actions 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
12/03/2020 T34 Ambulatory Syringe Pumps - Priority 2 – Warning Warning
11/03/2020 Programmable Ventriculo-Peritoneal (PVP) / Programmable Cerebrospinal Fluid (CSF) Shunts. Priority 3 – Advisory Advisory
06/03/2020 Giraffe Omnibed, Giraffe Incubator, Giraffe Omnibed Carestation, Giraffe Incubator Carestation. Priority 2 – Warning Warning
02/03/2020 Summary of Field Safety Notices - February 2020 3rd Party Publications
03/02/2020 Summary of Field Safety Notices – January 2020 3rd Party Publications
07/01/2020 Summary of Field Safety Notices - December 2019 3rd Party Publications
13/12/2019 Cordis S.M.A.R.T. and PRECISE Stents Warning
13/12/2019 Philips HeartStart XL+ Defibrillator/Monitor Warning
03/12/2019 Summary of Field Safety Notices - November 2019 3rd Party Publications
14/11/2019 Sulfasalazine Interference with laboratory tests - Priority 2 – Warning Warning
12/11/2019 Convex Two-Piece Skin Barriers (Natura /Surfit /Combihesive Wafers). Priority 2 – Warning Warning
05/11/2019 Summary of Field Safety Notices - October 2019 3rd Party Publications
01/10/2019 T34 Ambulatory Syringe Pumps - Update. Priority 2 – Warning Warning
01/10/2019 Summary of Field Safety Notices - September 2019 3rd Party Publications