Quality & complianceOfficial

BfArM publishes Funke Medical urgent field safety notice for mattress extensions

🇩🇪 BfArM field safety notices · Thu 05 Nov 2026

Germany's BfArM has listed a manufacturer advisory from Funke Medical GmbH on its Matratzenverlängerung, but the public entry gives no detail on the problem or the corrective action.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 5 November 2026 relating to mattress extensions (Matratzenverlängerung) made by Funke Medical GmbH. The entry carries reference 49125/26.

BfArM files the product under 'General equipment for medical treatment - furnishings'. The listing itself says nothing about the nature of the defect, the risks to patients or users, the affected models or batches, or the action the manufacturer is asking customers to take.

Instead, BfArM refers readers to the manufacturer's Advisory Notice, which is attached to the entry as a 343KB PDF. BfArM flags that the file does not meet accessibility standards. Anyone needing the specifics must therefore consult that document directly.

In general, a field safety notice is the document a manufacturer sends to users when it takes a field safety corrective action on a medical device already on the market. National authorities such as BfArM make these notices publicly available.

What it means for your team

  • Facilities that use Funke Medical mattress extensions should obtain and read the manufacturer's Advisory Notice attached to BfArM reference 49125/26.
  • Quality and vigilance teams should check whether affected products are in their inventory or supply chain and record the notice in their field-action tracking.
  • The BfArM listing does not describe the defect, risk or required action, so no assessment of severity or scope can be made from it alone.

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 →