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Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 2016
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Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.
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(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
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Regular safety information for healthcare professionals
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
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The BodyComm software currently uses Windows 10. Microsoft is transitioning to Windows 11 from 14 October 2025 which requires an updated cable to connect the pumps to the BodyComm software. These cables may not be available …
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Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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(All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)
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(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
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(Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)
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(All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
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Summary of the latest safety advice for medicines and medical device users
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(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)
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(All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)
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Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a ware…
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(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
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Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.
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(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
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(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)
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(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)
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(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.
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(All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)
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UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
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Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
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Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin…
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(Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)
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Medline Industries LP and Kimal PLC have identified safety issues with the Namic Angiographic Control Syringes with RA and Namic White Star Off Handle Manifold devices, and have issued field safety notices to affected UK hos…
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Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
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Summary of the latest safety advice for medicines and medical device users
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Manufactured by Abbott – cases of valvular insufficiency and early revision.
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The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).
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Philips Health Systems have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings …
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Summary of the latest safety advice for medicines and medical device users
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Summary of the latest safety advice for medicines and medical device users