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MHRA lists field safety notices for medical devices from Abbott, Baxter, Philips and others

🇬🇧 MHRA alerts · Wed 28 Oct 2026

The agency's weekly list for 19 to 23 October 2026 covers notices from 14 manufacturers, among them glucose monitoring, infusion pump, defibrillator and X-ray equipment.

The Medicines and Healthcare products Regulatory Agency (MHRA) published its list of Field Safety Notices (FSNs) for 19 to 23 October 2026 on 28 October. The page gives manufacturer names, product names and MHRA reference numbers, with links to letters for some entries. The extract available does not describe the safety issues or the corrective actions requested.

Abbott appears with the FreeStyle Libre 3 App, described as an invasive interstitial-fluid glucose monitoring system. B Braun is listed for Space Infusion Pumps, and Boston Scientific for OptiCross intravascular ultrasound imaging catheters. Hologic's Horizon DXA System, a dual-energy bone absorptiometric X-ray system, and a Shimadzu X-ray high voltage generator (UD and ZUD types) are also included.

HeartSine has a notice covering samaritan PAD models SAM 350P, 360P, 450P, 500P and HDF3500, with nine letters (A to I) attached. KayserBetten is listed for the Limoss Auto-Lock hand control on paediatric cots (models Olaf, Mascot, IDA, Emma, ES-Cot and variants), with separate distributor and end-user letters. Philips has an entry for IntelliVue patient monitors, models 866471, 866470, 867130 and 867133.

Other entries are Baxter (TruSystem), E&O Laboratories (Cooked Meat with Brain Heart Infusion Broth Overlay), RAL Diagnostics (FIX-RAL-555), Unisurge (custom made procedure packs and Steriflush syringes with NaCl 0.9% and with water) and Kimal (procedure packs). The Kimal notice, dated 26 October 2026, is an update to an earlier MHRA reference, 39391570. The notice dates shown range from August to October 2026.

The MHRA states that anyone who receives an FSN from a manufacturer must always act on it, and that it publishes the list for information only. Questions about a particular notice should go to the manufacturer.

What it means for your team

  • Check the full MHRA list and the linked manufacturer letters, because the summary does not set out the hazards or required actions.
  • Compare the named products and models with UK-marketed devices, procedure packs and consumables in your portfolio and supply chain, including those distributed or used by third parties.
  • Act on any FSN received directly from a manufacturer; the MHRA listing does not replace it.
  • Note the Kimal update, which refers to an earlier reference (39391570), and the multiple HeartSine letters, which may apply to different recipient groups.

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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