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
11/11/2011 Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs Advisory
04/11/2011 Contoura® 880 Series Hospital Bed Frames Advisory
02/11/2011 Field Safety Notice Monthly Summary Sheet - October 2011 3rd Party Publications
05/10/2011 Field Safety Notice Monthly Summary Sheet - September 2011 3rd Party Publications
05/10/2011 Mobile Patient Lifts - Uno, Viking S, Viking XS, LikoLight Advisory
02/09/2011 Field Safety Notice Monthly Summary Sheet - August 2011 3rd Party Publications
24/08/2011 Static Mattresses Advisory
19/08/2011 Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures Advisory
12/08/2011 Linet Eleganza Standard and Deluxe Model Bedframes Advisory
10/08/2011 Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner Recall
05/08/2011 Field Safety Notice Monthly Summary Sheet - July 2011 3rd Party Publications
19/07/2011 Unomedical Sterile Urine Drainage Bags Recall
15/07/2011 HARMONY LA, LC 500 and LA 700 SURGICAL LIGHTING and MEDIA SYSTEM Advisory
01/07/2011 Field Safety Notice Monthly Summary Sheet - June 2011 3rd Party Publications
27/06/2011 Medicine Feeders (incl. spoons, droppers, syringes, and pacifiers/soothers) Advisory
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