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BfArM publishes Intersurgical field safety notice for Smoothbore Breathing System

🇩🇪 BfArM field safety notices · Fri 30 Oct 2026

Germany's BfArM has listed an urgent field safety notice from Intersurgical Ltd. for its Smoothbore Breathing System, with all substantive details held in the manufacturer's attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 30 October 2026 concerning the Smoothbore Breathing System made by Intersurgical Ltd. The entry is filed under reference 50519/26.

BfArM classifies the product in the group 'Surgical equipment/Anaesthesia - anaesthesia and medical gas supply'. The listing itself does not describe the problem with the device, the affected batches or the actions users are expected to take.

Instead, BfArM refers readers to the manufacturer's Advisory Notice, attached to the entry as a 421KB PDF. The file is flagged on the BfArM site as not meeting accessibility standards. Facts on the defect, scope and corrective measures are therefore available only in that document.

As general context, a field safety notice is the communication a manufacturer sends to users and distributors when it takes a field safety corrective action on a marketed medical device. Regulators such as BfArM make these notices publicly available.

What it means for your team

  • Hospitals, anaesthesia departments and distributors handling Intersurgical Smoothbore Breathing Systems should read the manufacturer's Advisory Notice without delay to establish whether their stock is affected.
  • Quality teams should check inventory and traceability records against the details in the advisory, since the BfArM listing does not specify affected lots or actions.
  • Vigilance staff should note reference 50519/26 and ensure any required responses or acknowledgements requested by the manufacturer are completed and documented.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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