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
22/02/2017 Reyoungel Dermal Filler - Priority 2 - Warning Warning
16/02/2017 Oxylog 3000 and Oxylog 3000 plus Ventilators. Priority 2 – Warning Warning
16/02/2017 Disposable STA®-Cuvettes (Ref. 38669) For Haemostasis Analysers STA-R®, STA R MAX®, STA COMPACT®, STA COMPACT MAX®. Priority 2 – Warning Warning
09/02/2017 Caution when Purchasing Dental Devices Online - Information Notice Advisory
08/02/2017 ETEST® COLISTIN. Priority 2 – Warning Warning
02/02/2017 Summary of Field Safety Notice – January 2017 3rd Party Publications
31/01/2017 VITEK®2 AST-YS01 Test Kit, VITEK®2 AST-YS07 Test Kit. Priority 2 – Warning Warning
30/01/2017 BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor. Priority 2 – Warning Warning
27/01/2017 INNOVANCE D-Dimer on Sysmex CS Systems. Priority 2 – Warning Warning
17/01/2017 Romed 2-part syringes, 20 ml (Ref Number: SYR-20ML) Lots: 150608, 151015, 151204, 160202. Priority 2 – Warning Warning
16/01/2017 SynchroMed® II Implantable Infusion Pumps. Priority 2 – Warning Warning
04/01/2017 Summary of Field Safety Notices - December 2016 3rd Party Publications
21/12/2016 Life-Point Pro AED / bPLUS / mPLUS defibrillator devices and Adult Electrode Pads & Paediatric Electrode Pads. Priority 1 – Immediate Action For Immediate Action
15/12/2016 LMA® Mucosal Atomization Devices and LMA® MAD Nasal™ Intranasal Mucosal Atomization Devices. Priority 2 – Warning Warning
13/12/2016 Reflection Dead Blow Mallet. Priority 2 – Warning Warning
13/12/2016 Immucor Gamma Kleihauer Kit. Priority 2 – Warning Warning
13/12/2016 TOP-Q Super Fine Line TOP-Q Super Derm Line- Priority 2 Warning Warning
09/12/2016 CME T34 Ambulatory Syringe Pumps. Priority 3 – Advisory Advisory
05/12/2016 Summary of Field Safety Notice – November 2016 3rd Party Publications
05/12/2016 Multiple Ortho Reagent Red Blood Cell (RRBC) Products & - Control Reagent Products containing Red Blood Cells. Priority 2 – Warning Warning