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Published on 21 June 2021

Medical devices alerts

  • MDA/2020/021R, Masks: type IIR (originally distributed by Cardinal Health) – destroy all lots, issued on 24 Aug 20. Find further information on the GOV.UK website.
  • MDA/2020/022, Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed, issued on 23 Jul 20. Find further information on the GOV.UK website.
  • MDA/2020/021, Masks: type IIR from Cardinal Health – destroy affected lots, issued on 20 Jul 20. Find further information on the GOV.UK website.
  • MDA/2020/020, Depuy Synthes Spinal fixation system – risk of implant failure prior to completion of bone healing, issued on 10 Jul 20. Find further information on the GOV.UK website.
  • MDA/2020/019, Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD), issued on 06 Jul 20. Find further information on the GOV.UK website.
  • MDA/2020/018, Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail, issued on 30 Jun 20. Find further information on the GOV.UK website.
  • MDA/2020/017, Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation, issued on 29 Jun 20. Find further information on the GOV.UK website.
  • MDA/2020/016, Philips HeartStart MRx Monitor/Defibrillators may fail to deliver therapy without alerting the user to a fault, in the event of internal damage, issued on 17 Jun 20. Find further information on the GOV.UK website.
  • MDA/2020/015, Fingerprick blood sample collection kits & Laboratory based tests for COVID19 antibodies – unvalidated, issued on 08 Jun 20. Find further information on the GOV.UK website.
  • MDA/2020/014, Teleflex Pilling Clear Advantage aortic punch – risk of infection due to packaging failure, issued on 20 Apr 20. Find further information on the GOV.UK website.
  • MDA/2020/013, Covid-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up, issued on 10 Apr 20. Find further information on the GOV.UK website.
  • MDA/2020/012, Coronavirus COVID-19 pandemic and “off label” use of Anaesthetic machines, issued on 08 Apr 20. Find further information on the GOV.UK website.
  • MDA/2020/011, NuVasive Specialized Orthopedics - All MAGEC Systems – supply suspended to the UK, issued on 01 Apr 20. Find further information on the GOV.UK website.
  • MDA/2020/010, NuVasive Inc Spinal implant: MAGEC System Model X rods – risk of failure in use, issued on 18 Mar 20. Find further information on the GOV.UK website.
  • MDA/2020/009, Cardinal Genius 2 and Genius 3 tympanic thermometers – revision of the calibration frequency, issued on 27 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/008, Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users, issued on 27 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/007, CME (a BD company) All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm, issued on 25 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/006, Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents, issued on 13 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/005, Tandem Diabetes Care t: slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters, issued on 05 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/004, Mavidon skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection, issued on 05 Feb 20. Find further information on the GOV.UK website.
  • MDA/2020/003, Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy, issued on 28 Jan 20. Find further information on the GOV.UK website.
  • MDA/2020/002, ConvaTec Convex two-piece skin barriers (Natura /Surfit /Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier, issued on 16 Jan 20. Find further information on the GOV.UK website.
  • MDA/2020/001, NIPPY ventilator range (all models) – update to instructions for use, issued on 15 Jan 20. Find further information on the GOV.UK website.
  • MDA/2019/046, Teleflex Arrow EZ-IO® intraosseous vascular access needle sets – risk of needle stick injury, issued on 19 Dec 19. Find further information on the GOV.UK website. Find further information on the GOV.UK website.
  • MDA/2019/045, GE ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring, issued on 18 Dec 19. Find further information on the GOV.UK website.
  • MDA/2019/044, Flexicare Medical BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking, issued on 12 Dec 19. Find further information on the GOV.UK website.
  • MDA/2019/043, Medicina IV Luer Slip syringe (IVS03) Recall of batch number 19040303, issued on 11 Dec 19. Find further information on the GOV.UK website.
  • MDA/2019/042, Natus - GN Otometrics gold cup electrodes and snap electrode leads – risk of electric shock, issued on 05 Dec 19. Find further information on the GOV.UK website.
  • MDA/2019/041, Terumo Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use, issued on 04 Dec 19. Find further information on the GOV.UK website.
  • MDA/2019/040, Becton Dickinson Alaris™ Gateway Workstation and Alaris™ Gateway Workstation Web Browser User Interface, issued on 27 Nov 19. Find further information on the GOV.UK website.
  • MDA/2019/039, Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart, issued on 31 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/038, CME (a BD company) Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released, issued on 29 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/037, Prismaflex Haemofiltration Systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment, issued on 10 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/036, Teleflex Medical Hudson RCI Sheridan endotracheal tubes and connectors - risk of disconnection, issued on 10 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/035, Rocket and NuSurgix Fetal Blood Sampling (FBS) Amnioscopes – stop using ethyl chloride spray during the fetal blood sampling procedure, issued on 09 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/034, Ecolab/ Microtek Medical Malta Ltd Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected), issued on 09 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/033, Intersurgical anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit, issued on 08 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/032, Intersurgical Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use, issued on 03 Oct 19. Find further information on the GOV.UK website.
  • MDA/2019/031, Clinical Innovations Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected), issued on 30 Sep 19. Find further information on the GOV.UK website.
  • MDA2019/030, All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress, issued on 18 Sep 19. Find further information on the GOV.UK website.
  • MDA/2019/029, Smiths Medical Deltec Gripper ® non-coring Needles and PORT-A-CATH Trays containing Gripper ® Needles – recall due to risk of needle occlusion, issued on 12 Sep 19. Find further information on the GOV.UK website.
  • MDA/2019/028, Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection, issued on 27 Aug 19. Find further information on the GOV.UK website.
  • MDA/2019/027, Defiteq International BV or GGT Holding BV Automated external defibrillators: All Telefunken, HR1 & FA1 – no valid CE certificate, issued on 25 Jul 19. Find further information on the GOV.UK website.
  • MDA/2019/026, BD Microtainer® Tubes – risk of blood leakage and incorrect test results due to defective tubes, issued on 24 Jul 19. Find further information on the GOV.UK website.
  • MDA/2019/025, Philips IntelliVue MX40 patient worn monitors – increased power consumption and absent visual and audible notifications when in a low battery state, issued on 02 Jul 19. Find further information on the GOV.UK website.
  • MDA/2019/024R, BBraun Dialog+ SW versions 9.xx and <9.18 haemodialysis machines – upgrade of software required, issued on 26 Jun 19. Find further information on the GOV.UK website.
  • MDA/2019/024, BBraun Dialog+ SW versions 9.xx and <9.18 haemodialysis machines – upgrade of software required, issued on 26 Jun 19. Find further information on the GOV.UK website.
  • MDA/2019/023R, Paclitaxel drug coated balloons (DCBs) and implantable drug eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD) Recommendations for ongoing use, issued on 04 Jun 19. Find further information on the GOV.UK website.
  • MDA/2019/023, Paclitaxel drug coated balloons (DCBs) and implantable drug eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD) Recommendations for ongoing use, issued on 04 Jun 19. Find further information on the GOV.UK website.
  • MDA/2019/022, GE Healthcare Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 – risk of patient awareness due to inadequate anaesthesia, issued on 30 May 19. Find further information on the GOV.UK website.
  • MDA/2019/021, Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance, issued on 01 May 19. Find further information on the GOV.UK website.
  • MDA/2019/020, Etac Molift Mover 180/205 mobile hoist and Molift Air ceilings hoist 2-Point Sling Bars supplied between May 2013 and 1 October 2018– all sizes – risk of fracture of hooks in use, issued on 01 May 19. Find further information on the GOV.UK website.
  • MDA/2019/019, Ethicon Curved Intraluminal Staplers – risk of failure of staple lines, issued on 25 Apr 19. Find further information on the GOV.UK website.
  • MDA/2019/018, Fresenius 5008 haemodialysis machine – risk of inadequate fluid removal during treatment due to sudden failure of the Ultrafiltration (UF) Pump, issued on 29 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/017, Philips Pagewriter Cardiographs (TC20/30/50/70) and Efficia Monitors (CM10/12/100/120/150) – risk of batteries overheating or igniting, issued on 20 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/016, Vyaire enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer, issued on 19 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/015, Vyaire - enFlow™ IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device, issued on 08 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/014, All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed, issued on 07 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/013, All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues, issued on 04 Mar 19. Find further information on the GOV.UK website.
  • MDA/2019/012, Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps, issued on 28 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/011, GE Healthcare - Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring, issued on 27 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/010, Stryker LIFEPAK 15 Monitor/Defibrillator- possible failure to deliver therapy, issued on 20 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/009, Roche Diabetes Care Accu-Chek® Insight insulin pumps, serial numbers below 32100000 – Advice on fitting key frames to pump to reduce risk of unintentional activation of the bolus keys, issued on 19 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/008, Medtronic Dual chamber pacemakers - Risk of syncope due to pause in pacing therapy, issued on 13 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/007, Revsion Optics Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze, issued on 13 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/006, Stryker Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening, issued on 08 Feb 19. Find further information on the GOV.UK website.
  • MDA/2019/005, Recall of certain batches of Eurotrol Haemoglobin Controls – due to microbial contamination, issued on 30 Jan 19. Find further information on the GOV.UK website.
  • MDA/2019/004, ArjoHuntleigh AB Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts WITHOUT a scale, issued on 30 Jan 19. Find further information on the GOV.UK website.
  • MDA/2019/003, Abbott FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive, issued on 29 Jan 19. Find further information on the GOV.UK website.
  • MDA/2019/002, Endologix Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance, issued on 25 Jan 19. Find further information on the GOV.UK website.
  • MDA/2019/001, GE Healthcare Datex-Ohmeda Aisys devices software version 11 - Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension, issued on 17 Jan 19. Find further information on the GOV.UK website.