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

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
09/06/2005 'Tulip' Condoms Advisory
14/03/2005 Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms Recall
15/11/2004 AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices Recall
14/10/2004 Sterile Devices Advisory
20/09/2004 Invasive Blood Pressure Monitoring Devices with Transducers Advisory
13/08/2004 Haemodialysis Equipment Advisory
13/08/2004 Instructions for Use provided by the Medical Device Manufacturer Advisory
19/07/2004 Commercial Automated Antimicrobial Susceptibility Tests and Disc Diffusion Tests for the Detection o Advisory
14/07/2004 The “Intended Purpose” of a Medical Device Advisory
19/04/2004 Switch Controlled (Electric) Height Adjustable Beds Advisory
12/03/2004 Cervical Halo Traction Apparatus Warning
12/03/2004 Blood Pressure and Vital Signs Patient Monitor DINAMAP Pro 100 - 400 Series Warning
15/12/2003 Equipment Management: Some Basic Principals of Equipment Management Advisory
15/12/2003 Equipment Management: Guidance for the Maintenance and Timely Replacement of Medical Equipment Advisory
09/10/2003 Patient Hoist, Liftmaster models 110, 160, & 190 Warning
10/09/2003 Lubby Baby New-Safe Medicine Feeder Recall
21/03/2003 Adrett Kranken – Schutzdecke Bettschurze Warning
26/02/2003 SC7000 & SC9000 Patient Monitors Warning
14/02/2003 Cardiotocograph Advisory
13/02/2003 Broviac Paediatric Catheter Advisory