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
03/12/2019 Field Safety Notice Summary Sheet - Outstanding Actions 3rd Party Publications
03/12/2019 Summary of Field Safety Notices - November 2019 3rd Party Publications
14/11/2019 Sulfasalazine Interference with laboratory tests - Priority 2 – Warning Warning
12/11/2019 Convex Two-Piece Skin Barriers (Natura /Surfit /Combihesive Wafers). Priority 2 – Warning Warning
01/10/2019 T34 Ambulatory Syringe Pumps - Update. Priority 2 – Warning Warning
01/10/2019 Summary of Field Safety Notices - September 2019 3rd Party Publications
09/09/2019 Summary of Field Safety Notices - August 2019 3rd Party Publications
15/08/2019 Feeding Tubes, Nelaton Catheters, Levins Tubes, Rectal Catheter, Ryles Tubes, Suction Catheters, Stomach Tubes, Medical Packs. Priority 2 – Warning Warning
01/08/2019 Summary of Field Safety Notices - July 2019 3rd Party Publications
18/07/2019 Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. Priority 1 – For Immediate Action For Immediate Action
16/07/2019 MiniMed™ Paradigm™ Series and MiniMedTM 508 Insulin Pumps. Priority 2 – Warning Warning
08/07/2019 HeartStart MRx (M3539A AC Power Module). Priority 2 – Warning Warning
03/07/2019 Counterfeit Regenyal Idea Body 1X20ML. Priority 2 – Warning Warning
01/07/2019 Summary of Field Safety Notices - June 2019 3rd Party Publications
26/06/2019 Lone Star® Single-Use Elastic Stays and CPO-6 Colpo-Pneumo Occluder. Priority 2 – Warning Warning
17/06/2019 Electro–Surge Limited Devices used in Electrosurgery Advisory
14/06/2019 Endo GIA Surgical Stapling Single Use Loading Units, Tri-Staple 2.0 Intelligent Reloads and Cartridges. Priority 1 – For Immediate Action For Immediate Action
07/06/2019 Medtronic Implantable Pacemaker & CRT-P Devices. Affected Models: Azure™, Astra™, Percepta™, Serena™, Solara™ . Priority 2 – Warning Warning
06/06/2019 Summary of Field Safety Notices - May 2019 3rd Party Publications
31/05/2019 Sheridan Close Fitting Endotracheal Tube,Sheridan Endotracheal Tube, Sheridan HVT Endotracheal Tube, Sheridan HVT EZ-Endo Endotracheal Tube, Sheridan Preformed Endotracheal Tube, Sheridan Uncuffed Endotracheal Tube. Priority 1 – For Immediate Action For Immediate Action