MHRA publishes field safety notices for 19–23 October 2026

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) published its field safety notice listing titled “19 to 23 October 2026” on 28 October. It brings together manufacturer notices across several device and product groups, including separate recipient-specific letters for some entries.

MHRA says it publishes the notices for information only. It states that recipients must always act on a manufacturer’s field safety notice and should contact the manufacturer with questions about an individual notice.

Who Is Affected

Entries include Abbott’s FreeStyle Libre 3 App, Baxter TruSystem, B Braun Space Infusion Pumps, Boston Scientific OptiCross intravascular ultrasound imaging catheters and HeartSine samaritan PAD devices. The HeartSine entry names models SAM 350P, 360P, 450P, 500P and HDF3500.

Also listed are Hologic Horizon-W and Horizon-WI DXA systems, KayserBetten Limoss Auto-Lock hand controls and Philips IntelliVue patient monitor models 866471, 866470, 867130 and 867133.

Further entries cover an E&O Laboratories culture-medium product, Kimal procedure packs, RAL Diagnostics FIX-RAL-555, SHIMADZU UD and ZUD type X-ray high voltage generators, and Unisurge procedure packs and Steriflush syringes. Product names alone do not establish which individual units or lots are affected; that scope requires the relevant manufacturer notice.

Regulatory and Technical Implications

The MHRA listing does not describe product-specific defects, clinical risks or detailed corrective actions. It therefore does not establish a common recall, stop-use instruction or software change across the entries.

The Kimal procedure-pack entry carries MHRA reference 41270391 and is explicitly identified as an update to reference 39391570, providing a connection to an earlier record.

Manufacturer Actions

Manufacturers are the designated contact for questions about their notices. MHRA’s general instruction is for recipients to act on the manufacturer’s notice; the listing does not prescribe one corrective action for every product.

The Baxter entry includes MOH and customer letters. KayserBetten has distributor and end-user letters, while HeartSine has letters A through I. These distinctions make identifying the applicable correspondence important.

Confirmed Dates

The page records publication on 28 October 2026 and a separate issued date of 27 October 2026. Its title identifies the period 19–23 October, but individual notice dates extend beyond that interval.

The Philips entry is dated 25 August, HeartSine September, Boston Scientific 22 October and Kimal 26 October 2026. The listing does not explain how these dates relate to the titled period and does not state a common action deadline.

Official Source

MHRA, “Field Safety Notices: 19 to 23 October 2026”, GOV.UK. The page lists the manufacturer notices and associated MHRA references.

Https://www.gov.uk/drug-device-alerts/field-safety-notices-19-to-23-october-2026