Quality & complianceOfficial

BfArM publishes urgent field safety notice for TRACOE vario from TRACOE medical

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

The German regulator has posted a field safety notice from TRACOE medical GmbH for its TRACOE vario device, but the listing refers readers to the manufacturer's attached Advisory Notice for details.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 28 October 2026 for TRACOE vario, a product of TRACOE medical GmbH, based in Nieder-Olm.

BfArM lists the item under reference 50238/26 and classifies it in the product group surgical equipment, specifically anaesthesia and medical gas supply.

The BfArM entry itself gives no details of the problem, the affected batches or the actions required. It says only that further information and device details are in the manufacturer's enclosed Advisory Notice, which is available as a 453 KB PDF download.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes corrective action on a marketed medical device for safety reasons. The regulator publishes it so that affected users can find it.

What it means for your team

  • Download and read the manufacturer's Advisory Notice, since the BfArM listing does not state the issue, affected lots or required actions.
  • Hospitals, distributors and other holders of TRACOE vario products should check their stock and sites against the Advisory Notice to confirm whether they are affected.
  • Vigilance and quality teams should log reference 50238/26 and record any actions taken in line with their own procedures.

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.

More Quality & compliance All →