tag:www.gov.uk,2005:/drug-device-alerts Alerts, recalls and safety information: medicines and medical devices about Orthopaedics 2026-04-29T14:02:41+01:00 HM Government tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-april-2026 2026-04-29T14:02:41+01:00 MHRA Safety Roundup: April 2026 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-march-2026 2026-03-31T14:01:53+01:00 MHRA Safety Roundup: March 2026 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-regent-medical-limited-slash-molnlycke-health-care-hibiwash-500ml-el-26-a-slash-15 2026-03-23T16:32:53+00:00 Class 2 Medicines Recall: Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml, EL(26)A/15 Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-quetiapine-oral-suspension-unlicensed-medicine-manufactured-by-eaststone-limited-due-to-a-potential-for-overdosing-natpsa-slash-2026-slash-002-slash-mhr 2026-01-29T12:13:05+00:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Quetiapine Oral Suspension (unlicensed medicine), manufactured by Eaststone Limited due to a potential for overdosing, NatPSA/2026/002/MHRA Eaststone Limited is initiating a recall of all batches of quetiapine oral suspension products due to a potential risk of overdose, which could have consequences for the safety of patients. tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-january-2026 2026-01-27T14:00:25+00:00 MHRA Safety Roundup: January 2026 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/m6-c-artificial-cervical-disc-spinal-kinetics-llc-new-monitoring-requirements-for-the-risk-of-osteolysis 2026-01-15T14:00:17+00:00 M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001) The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc. tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-november-2025 2025-11-27T14:05:40+00:00 MHRA Safety Roundup: November 2025 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-october-2025 2025-10-28T14:28:26+00:00 MHRA Safety Roundup: October 2025 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-september-2025 2025-09-30T13:59:39+01:00 MHRA Safety Roundup: September 2025 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-005 2025-09-04T10:07:02+01:00 Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005) An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem compone… tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-august-2025 2025-08-28T14:59:53+01:00 MHRA Safety Roundup: August 2025 Summary of the latest safety advice for medicines and medical device users tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-pfizer-limited-oxbryta-500mg-tablets-voxelotor-el-24-a-slash-44 2024-09-30T13:15:15+01:00 Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor), EL(24)A/44 Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies. tag:www.gov.uk,2005:/drug-device-alerts/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-007 2024-09-04T11:02:03+01:00 CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007 Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a sim… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30 2024-07-22T15:01:01+01:00 Class 2 Medicines Recall: Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion, EL(24)A/30 Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-desitin-pharma-uk-ltd-lamotrigine-desitin-10mg-slash-ml-oral-suspension-el-24-a-slash-20 2024-06-06T13:59:27+01:00 Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension, EL(24)A/20 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… tag:www.gov.uk,2005:/drug-device-alerts/symbios-origin-r-posterior-stabilised-patient-matched-total-knee-replacement-device-risk-of-early-revision-dsi-slash-2024-slash-005 2024-04-23T11:31:22+01:00 Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, DSI/2024/005 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. tag:www.gov.uk,2005:/drug-device-alerts/0-dot-9-percent-sodium-chloride-solutions-for-irrigation-inhalation-and-eyewash-recall-from-manufacturer-legency-remedies-dsi-slash-2024-slash-004 2024-04-04T14:02:30+01:00 0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004 Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination. tag:www.gov.uk,2005:/drug-device-alerts/magec-x-system-nuvasive-specialized-orthopedics-nso-uk-suspension-lifted-dsi-slash-2024-slash-002 2024-03-12T15:12:07+00:00 MAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted, (DSI/2024/002) The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-limited-adakveo-10-mg-slash-ml-concentrate-for-solution-for-infusion-el-24-a-slash-06 2024-02-21T10:56:35+00:00 Class 2 Medicines Recall: Novartis Pharmaceuticals UK Limited, Adakveo 10 mg/ml concentrate for solution for infusion, EL(24)A/06 Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-medical-beds-trolleys-bed-rails-bed-grab-handles-and-lateral-turning-devices-risk-of-death-from-entrapment-or-falls-natpsa-slash-2023-slash-010-slash-mhra 2023-08-30T14:30:55+01:00 National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA) The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles. tag:www.gov.uk,2005:/drug-device-alerts/ethypharm-aurum-pre-filled-syringes-are-incompatible-with-some-manufactured-needle-free-connectors-risk-of-delay-in-administering-potentially-lifesaving-medication-dsi-slash-2023-slash-008 2023-08-22T11:51:33+01:00 Ethypharm Aurum pre-filled syringes are incompatible with some manufactured needle-free connectors: risk of delay in administering potentially lifesaving medication, DSI/2023/008 Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-b-braun-medical-ltd-various-products-el-23-a-slash-27 2023-07-31T12:55:32+01:00 Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27 B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18 2023-05-22T14:00:14+01:00 Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18 Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-emerade-500-micrograms-and-emerade-300-micrograms-auto-injectors-due-to-the-potential-for-device-failure-natpsa-slash-2023-slash-004-slash-mhra 2023-05-09T12:30:14+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors. tag:www.gov.uk,2005:/drug-device-alerts/nuvasive-specialized-orthopedics-nso-precice-titanium-systems-uk-suspension-lifted-dsi-2023-slash-006 2023-04-12T09:59:41+01:00 NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006 The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte … tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-pholcodine-containing-products-el-23-a-slash-09 2023-03-14T11:01:17+00:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09 Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution. tag:www.gov.uk,2005:/drug-device-alerts/nexgen-knee-replacement-affected-patients-should-be-offered-additional-follow-up 2023-02-15T12:43:56+00:00 NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003 The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem… tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-november-2022 2022-11-28T15:34:54+00:00 Field Safety Notices: 21 to 25 November 2022 List of Field Safety Notices (FSNs) from 21 to 25 November 2022 tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits 2022-11-10T13:00:37+00:00 National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA 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. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-targocid-200mg-powder-for-solution-for-injection-slash-infusion-or-oral-solution-aventis-pharma-limited-t-slash-a-sanofi-due-to-the-presence-of-bacteria 2022-10-21T11:00:35+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-hikma-pharmaceuticals-usa-inc-lorazepam-2mg-slash-ml-injection-lorazepam-4mg-slash-ml-injection-unlicensed-medicines 2022-08-30T11:00:10+01:00 Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37 Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-mexiletine-hydrochloride-50mg-100mg-and-200-mg-hard-capsules-clinigen-healthcare-ltd-due-to-a-potential-for-underdosing-and-slash-or-overdosing-natpsa-s 2022-08-04T14:28:26+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-fresenius-kabi-limited-sodium-bicarbonate-1-dot-26-percent-solution-for-infusion-el-22-a-slash-20 2022-04-28T13:00:27+01:00 Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20 Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34 2021-12-01T16:55:42+00:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34 Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-vygoris-limited-mitocin-mitomycin-20mg-powder-for-solution-for-injection-slash-infusion-or-intravesical-use-el-21-a-slash-27 2021-11-08T11:34:13+00:00 Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use, EL (21)A/27 Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (&gt… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20 2021-08-25T13:00:19+01:00 Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20 Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19 2021-08-09T11:00:31+01:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19 Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-xomolix-2-dot-5-mg-slash-ml-solution-for-injection-el-21-a-slash-15 2021-07-01T11:00:57+01:00 Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15 Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14 2021-06-17T10:00:43+01:00 Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products, EL (21)A/14 Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-co-codamol-30-slash-500-effervescent-tablets-batch-1k10121-zentiva-pharma-uk-ltd-due-to-precautionary-risk-of-causing-overdose-natpsa-slash-2021-slash-0 2021-06-16T11:00:08+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA 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 … tag:www.gov.uk,2005:/drug-device-alerts/recall-of-bd-venflon-pro-safety-iv-cannula 2021-05-20T11:14:17+01:00 Recall of BD Venflon Pro safety and Venflon Pro IV cannula (DSI/2021/006R) Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port. tag:www.gov.uk,2005:/drug-device-alerts/targeted-communication-ce-mark-suspended-for-all-magec-systems-manufactured-by-nuvasive-specialized-orthopedics-inc 2021-05-10T15:51:13+01:00 Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (DSI/2021/007) Recommendations for clinicians including not implanting these devices tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-supply-disruption-of-sterile-infusion-sets-and-connectors-manufactured-by-becton-dickinson-bd-natpsa-slash-2021-slash-001-slash-mhra 2021-03-11T16:33:47+00:00 National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA) BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider. tag:www.gov.uk,2005:/drug-device-alerts/targeted-letter-implantable-orthopaedic-devices-manufactured-by-implants-international-ltd-trading-as-xtremity-solutions-ltd 2021-02-26T15:30:24+00:00 Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (DSI/2021/002) Unknown risks following distribution of product after CE certificate withdrawal tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-eaststone-limited-midabuc-midazolam-as-hcl-10mg-slash-ml-oromucosal-solution-el-21-a-slash-04 2021-02-16T10:00:09+00:00 Class 2 Medicines Recall: Eaststone Limited, MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04 Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-ambisome-liposomal-50-mg-powder-for-dispersion-for-infusion-pl-16807-slash-0001-el-21-a-slash-03 2021-02-11T12:30:38+00:00 Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03 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-… tag:www.gov.uk,2005:/drug-device-alerts/company-led-drug-alert-optiray-300mg-i-ml-solution-for-injection-or-infusion-pl-12308-0028-and-optiray-350mg-i-ml-solution-for-injection-or-infusion-pl-12308-0032 2020-10-22T15:00:29+01:00 Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032) Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of… tag:www.gov.uk,2005:/drug-device-alerts/spinal-fixation-system-risk-of-implant-failure-prior-to-completion-of-bone-healing-mda-2020-020 2020-07-10T10:30:51+01:00 Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020) Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing. tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-xl-defibrillator-monitor-therapy-selector-switch-may-fail-mda-2020-018 2020-06-30T10:00:03+01:00 Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018) Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy. tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-mrx-monitor-defibrillators-may-fail-to-deliver-therapy-without-alerting-the-user-to-a-fault-in-the-event-of-internal-damage-mda-2020-016 2020-06-17T14:01:13+01:00 Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016) The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.