Archive for MHRA Updates
Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
Source: MHRA 17.9.26 The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal...
Class 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd
Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38 Source: MHRA 17.9.26 Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode...
National Patient Safety Alert: Patient hoists and slings (all types)
:risk of death and serious harm from falls (NatPSA/2026/005/MHRA) Source: MHRA 16.9.26 Fatal and serious harm continues to occur when patients fall from hoists or slings during transfers and repositioning....
Source: MHRA 24.8.26 The NGPod handheld device and NGPod sensor, used to test pH to aid the placement of nasogastric tubes, is being withdrawn from the UK market. The manufacturer...
National Patient Safety Alert: ResMed Astral 100 and 150 Ventilators:
Potential for Patient Harm due to Unexpected Interruption of Ventilation Therapy (NatPSA/2026/004/MHRA) Source: MHRA 17.8.26 ResMed has issued a Field Safety Notice regarding Astral 100 and 150 ventilators and associated...
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Source: MHRA 20.8.26 Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination...
All rectal catheters (gas and colic relievers):
Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation (DSI/2026/008) Source: MHRA 18.8.26 Do not use rectal catheters in infants, including for colic, gas-related...
Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
Source: MHRA 10.08.2026 The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK...
Belzer UW® Cold Storage Solution and Belzer MPS® (UW Machine Perfusion Solution): manufactured by Carnamedica (UKRP: Bridge to Life): Updated advice on the contamination of fluid DSI/2026/006 (update to DSI/2023/005)
Source: MHRA 06.08.2026 The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005 Summary The...
Dräger Atlan Anaesthesia workstations: risk of ventilator failure (DSI/2026/005)
Source: MHRA 04.08.2026 In April 2026, Dräger issued a follow-up Field Safety Notice expanding the number of Atlan Anaesthesia workstation devices affected by a manufacturing defect that may result in...
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Source: MHRA 23.07.2026 Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of...
Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets, EL(26)A/35
Source: MHRA 20.07.2026 Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of...
