MHRA lists field safety notices for eight products

What Changed

The UK Medicines and Healthcare products Regulatory Agency (MHRA) lists field safety notices (FSNs) for eight products on a page stating a publication date of 9 October 2026. MHRA says the list is provided for information only.

The title identifies the period as 28 September–2 October 2026, but the introductory description refers to 21–25 September 2026. The supplied text therefore does not establish a consistent reporting period.

Who Is Affected

Entries cover Alba Bioscience ORTHO Sera Anti-Fyb; B Braun RV1000NC SAFSITE VENTIL W/O EXTRA KAPPE; Medtronic Auto Suture Structural Balloon & Blunt Tip Trocar; and Philips Radiography 7000 M.

The remaining entries concern Reliance Medical Traumafix; Roche Diagnostics cobas c 303 analytical unit; Silvalea Dress Sling Poly Grey Ex Ex Large; and TRACOE Tracoe Vario Tracheostomy Tube/Experc Set Vario.

Organisations using or supplying these products should refer to the corresponding manufacturer notice. Inclusion in this summary does not establish that every unit or batch of a named product is affected.

Regulatory and Technical Implications

MHRA explicitly states that recipients must always act on a manufacturer's FSN and should direct questions about a particular notice to the manufacturer.

The list identifies Philips model 712010 and Roche model 09031529001, alongside multiple Medtronic and TRACOE model references. It does not describe the underlying hazards, affected batches or corrective instructions. A universal recall or stop-use instruction cannot be inferred from this summary.

Manufacturer Actions

The supplied summary does not introduce a new manufacturer reporting requirement or implementation timetable. Product-specific scope and actions must be assessed using the relevant manufacturer notice.

Product names, models and MHRA references can help match entries to notices. For example, the Roche entry carries notice reference SBN-RDS-CoreLab-2026-007 and MHRA reference 40982662. The summary is not a substitute for the original instructions.

Confirmed Dates

The source states publication on 9 October 2026 and a page-level issued date of 28 September 2026. The conflicting reporting periods in the title and introduction remain unresolved.

Individual entries are dated 28 September for Alba Bioscience, 25 September for B Braun, 30 September for Reliance Medical and 7 September 2026 for TRACOE. Medtronic is dated only August 2026 and Philips September 2026. No separate notice date is supplied for Roche or Silvalea, and no action-completion deadline is stated.

Official Source

MHRA: Field Safety Notices: 28 September 2026 to 2 October 2026. This report is limited to the supplied list; the individual manufacturer notices are not included in the source text.

https://www.gov.uk/drug-device-alerts/field-safety-notices-28-september-2026-to-2-october-2026