Quality & complianceOfficial

MHRA lists 13 medical device field safety notices for week of 26–30 October

🇬🇧 MHRA alerts · Wed 04 Nov 2026

The UK regulator's weekly roundup names manufacturers including Abbott, Philips, Abiomed and Beckman Coulter, but gives no detail on the nature of the problems.

The Medicines and Healthcare products Regulatory Agency (MHRA) published its weekly list of field safety notices (FSNs) on 4 November 2026, covering 26 to 30 October. The page lists 13 entries, each with an MHRA reference number.

Products named include Abbott's FreeStyle Libre 3 App, Abiomed's Automated Impella Controller, Beaver-Visitec's Mini-Blade and Lamellar Blade products, and Beckman Coulter's Access HIV Ag/Ab Combo Calibrator. Others are Datex-Ohmeda's Carestation 850, DH Healthcare's ORBIS Medication 3.x, Elekta's MOSAIQ and exocad's exoplan dental software.

The list also covers Fresenius Medical Care's 6008 CAREsystem, Full Support Healthcare's Easigown Comfort Surgical Gown, Keeler's Slimline Lithium Battery (Rev. A), Philips' Azurion systems and Sysmex's CN-3000, CN-6000, CN-3500 and CN-6500 analysers. Some entries carry model numbers; the Philips Azurion entry lists 14.

The source text does not describe the issue or the action required for any individual notice. Listed notice dates range from 25 September to 2 November 2026, and some entries show only a month or no date. The MHRA says the list is for information only. Anyone who receives an FSN from a manufacturer must act on it, and questions about a specific notice should go to the manufacturer.

What it means for your team

  • Check the list against devices your organisation makes, distributes or uses, including software and consumables such as surgical gowns and batteries.
  • Do not rely on the MHRA list for detail: use the manufacturer's FSN to determine the risk and the corrective action.
  • Confirm that any FSNs already received from manufacturers have been logged, assessed and acted on, as the MHRA says they must be.
  • Direct queries about individual notices to the relevant manufacturer rather than the regulator.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

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