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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 2017.
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List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
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List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 2017
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Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 - 17 March 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 09 June to 13 July 2018.
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List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 2019
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Summary List of field safety notices (FSNs) from medical device manufacturers from 31 October - 4 November 2016
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List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 October
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Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020
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List of field safety notices (FSNs) from medical device manufacturers from 2 May to 6 May 2016
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List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 February 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 September 2019.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 2019
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 August 2019.
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List of Field Safety Notices from 26 February to 1 March 2024
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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 2019
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Following our latest review of medical device alerts, we have archived the ones listed below.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016
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List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2015
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Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 - 7 October 2016
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…with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral, had a higher overall revision rate and a higher revision rate for aseptic tibial loosening compared to the average revision rate of all other total knee replacements…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021
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The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
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Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
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Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
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The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
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The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use.
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Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…
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Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 a…
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(Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)
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Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
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Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a prec…
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(Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Replaces drug alert issued on 29 April 2013 (EL 13(A)13 Rev 1)
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
…Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps…
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(Penn Pharma, distributed in Quantum Pharmaceutical livery) May result in evaporation of aqueous component of product and increase in concentration of Midazolam. (EL (14)/A10)
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(St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)
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Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for …
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.