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
17/06/2011 Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons* & Flents Paediatric Urine Collectors * Includes ‘Duffy Dog’ and ‘Kyle Crocodile’ Medicine Spoons Recall
15/06/2011 Explorer Loop 4 Wheeled Rollator Recall
13/06/2011 Millennium Oxygen Concentrator Advisory
13/06/2011 Contec Devices including Pulse Oximeters, Patient monitors, Ambulatory Blood Pressure Monitors, Spirometers, Pocket fetal dopplers, B-Ultrasound Diagnostic Systems, ECG's Advisory
09/06/2011 Patient Monitor CMS7000 Advisory
03/06/2011 Field Safety Notice Monthly Summary Sheet - May 2011 3rd Party Publications
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
09/05/2011 Field Safety Notice Monthly Summary Sheet - April 2011 3rd Party Publications
13/04/2011 Safe Use of Blood Glucose Monitoring Systems Advisory
08/04/2011 Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units Recall
07/04/2011 Field Safety Notice Monthly Summary Sheet - March 2011 3rd Party Publications
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
04/03/2011 Field Safety Notice Monthly Summary Sheet - February 2011 3rd Party Publications
23/02/2011 Counterfeit Medical Devices Advisory