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
05/08/2016 Immucor Gamma Kleihauer Kit. Priority 2 – Warning Warning
04/08/2016 VITEK®2 AST-YS07 Test Kit. Priority 2 – Warning Warning
03/08/2016 Summary of Field Safety Notice – July 2016 3rd Party Publications
21/07/2016 TRUEresult Blood Glucose Test Strips (GDH-PQQ). Priority 2 – Warning Warning
05/07/2016 Taperloc Lateralised PC Stem. Priority 2 – Warning Warning
04/07/2016 Summary of Field Safety Notices – June 2016 3rd Party Publications
01/07/2016 Pro-PICC CT & Pro-Line CT. Priority 2 – Warning Warning
29/06/2016 General Electrosurgery Guidance including “Flying Leads”. Priority 3 – Warning Warning
20/06/2016 RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette. Priority 2 – Warning Warning
15/06/2016 Telefunken AED Model HR1 & FA1. Priority 2 – Warning Warning
03/06/2016 M2a 38mm Acetabular System. Priority 2 – Warning Warning
02/06/2016 Summary of Field Safety Notices - May 2016 3rd Party Publications
02/06/2016 FLUOROCELL PLT. Priority 2 – Warning Warning
12/05/2016 Counterfeit Prime & Bond NT Refill - Priority 3 - Advisory Update Advisory
03/05/2016 Summary of Field Safety Notice – April 2016 3rd Party Publications
29/04/2016 Zelos PTA Balloon Catheter. Priority 1 – For Immediate Action For Immediate Action
29/04/2016 Endobon Xenograft Granules. Priority 2 – Warning Warning
29/04/2016 LOVEXOK One Step Pregnancy (HCG) Test Strips. Priority 2 – Warning Advisory
25/04/2016 Cross Reactivity Of Fulvestrant in Estradiol Assays. Priority 3 – Advisory. Advisory
07/04/2016 Risk associated with Wall mounted and Ceiling mounted Devices. Priority 3 – Advisory Advisory