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
09/06/2011 Patient Monitor CMS7000 Advisory
01/06/2011 ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper Advisory
26/05/2011 Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers) Advisory
23/05/2011 Zoll AED Plus Defibrillator Advisory
13/05/2011 Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen Advisory
12/05/2011 Ondal Acrobat 2000 (AC2000) Advisory
13/04/2011 Safe Use of Blood Glucose Monitoring Systems Advisory
05/04/2011 Installation and Compatibility of Medical Devices Advisory
01/04/2011 BHM Medical Inc. Hoists Advisory
11/03/2011 IMB Safety Notice: Liftmaster 160 (AA8974), Liftmaster 190 (AA8943) Advisory
23/02/2011 Counterfeit Medical Devices Advisory
04/02/2011 Counterfeit Medical Devices 04.02.2011 Advisory
21/01/2011 Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors Advisory
22/12/2010 Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010 Advisory
21/12/2010 Safe Use of Insulin Pens Advisory
17/12/2010 Installation and Compatibility of Medical Devices 17.12.2010 Advisory
01/11/2010 Single Use & Single Patient Use Medical Devices Advisory
05/10/2010 Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers) 05.10.2010 Advisory
30/09/2010 Stryker Model 6100 M1 Ambulance Cot Advisory
16/09/2010 Cleaning and Decontamination of Reusable Medical Devices Advisory