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
09/12/2016 CME T34 Ambulatory Syringe Pumps. Priority 3 – Advisory Advisory
10/11/2016 Accu-Chek Aviva Combo, Accu-Chek Mobile bGM system, Accu-Chek Spirit Combo, Accu-Chek Spirit and Spirit Combo insulin pump. Priority 3 – Advisory Advisory
12/05/2016 Counterfeit Prime & Bond NT Refill - Priority 3 - Advisory Update Advisory
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
08/01/2016 Manufacturer Field Safety Notices & HPRA Safety Notices. Priority 3 – Advisory Advisory
06/11/2015 New Format of HPRA Safety Notices. Priority 3 – Advisory Advisory
21/05/2015 Interference Of N-Acetylcysteine (NAC) with Enzyme-based Assays Used following Paracetamol Overdose. Priority 3 - Advisory Advisory
15/05/2015 Medtronic Synchromed II Implantable Infusion Pump Systems Advisory
24/03/2015 HPRA Information Notice - Food Intolerance Testing Advisory
13/03/2015 Invacare Leo®, Orion® and Comet ® Scooters. Priority 2 – Warning Advisory
23/02/2015 Information Notice - Medical devices supplied by Atrium Medical (Maquet) Advisory
05/02/2015 Counterfeit Toshiba Ultrasound Transducers - Priority 3 - Advisory Advisory
02/02/2015 Medical Devices in the Home. Priority 3 – Advisory Advisory
06/11/2014 Insulin Infusion Pumps. Priority 3 – Advisory Advisory
11/08/2014 ArjoHuntleigh lifting poles with an adjustable strap and handle. Priority 3 – Advisory Advisory
06/08/2014 Magnetic Resonance Imaging Safety. Priority 3 – Advisory Advisory
25/06/2014 “Intended Purpose” of a Medical Device. Guidance for healthcare settings -Priority 3 – Advisory Advisory
23/06/2014 Alaris® SmartSite® Needle-Free Valve. Product Reference: 2000E7D. Priority 2 – Recall Advisory