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
29/04/2016 LOVEXOK One Step Pregnancy (HCG) Test Strips. Priority 2 – Warning Advisory
25/04/2016 Cross Reactivity Of Fulvestrant in Estradiol Assays. Priority 3 – Advisory. Advisory
07/04/2016 Risk associated with Wall mounted and Ceiling mounted Devices. Priority 3 – Advisory Advisory
04/04/2016 Summary of Field Safety Notice – March 2016 3rd Party Publications
15/03/2016 G4 PLATINUM and G5 Mobile Receivers. Priority 2 – Warning Warning
03/03/2016 Summary of Field Safety Notices - February 2016 3rd Party Publications
09/02/2016 Contour NEXT Control Solution. Priority 2 – Warning Warning
02/02/2016 CME Syringe Extension Sets and T34 Ambulatory Syringe Pumps. Priority 2 – Warning Warning
02/02/2016 Summary of Field Safety Notice – January 2016 3rd Party Publications
28/01/2016 Smith & Nephew Birmingham Hip Modular Head. Priority 2 – Warning Warning
22/01/2016 Magnetom Systems – Superconducting Magnets. Priority 2 – Warning Warning
08/01/2016 Manufacturer Field Safety Notices & HPRA Safety Notices. Priority 3 – Advisory Advisory
05/01/2016 Summary of Field Safety Notices – December 2015 3rd Party Publications
23/12/2015 GlucoMen LX Sensor Test Strips. Priority 2 – Warning Warning
18/12/2015 Absorbent Pad and Surgapad. Priority 2 – Warning Warning
15/12/2015 Etest® Piperacillin / Tazobactam. Priority 1 – For Immediate Action For Immediate Action
04/12/2015 Allura Xper/Allura Centron/Allura Clarity/CV20. Priority 2 – Warning Warning
02/12/2015 Summary of Field Safety Notice – November 2015 3rd Party Publications
06/11/2015 New Format of HPRA Safety Notices. Priority 3 – Advisory Advisory
05/11/2015 PVC Paediatric Enteral Feeding Tube. Priority 2 – Warning Warning