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BfArM publishes field safety notice for Richter Rubber Technology condoms

🇩🇪 BfArM field safety notices · Thu 12 Nov 2026

Germany's BfArM has listed an urgent field safety notice from Richter Rubber Technology Sdn Bhd on condoms, but the public entry gives no details of the problem.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 12 November 2026 from Richter Rubber Technology Sdn Bhd. It concerns condoms sold under the Richter Rubber Technology name and is filed under the product group "Contraception - condoms" with reference 52208/26.

The BfArM entry does not describe the defect or the reason for the notice. It does not name affected batches or lot numbers, and it does not set out what users, distributors or healthcare facilities should do. It simply directs readers to the manufacturer's Advisory Notice, attached as a 2MB PDF.

Because the Advisory Notice is the only source of those details, the scope and seriousness of the issue cannot be judged from the public listing alone. As general context, a field safety notice is the document manufacturers use to inform customers of a corrective action involving a medical device already on the market.

What it means for your team

  • Obtain and read the full Advisory Notice to establish the defect, the affected products and any required action.
  • Distributors, importers and retailers should check whether Richter Rubber Technology condoms are in their supply chain, and quote reference 52208/26 when doing so.
  • Do not infer batch scope or risk level from the BfArM listing; none is stated there.
  • Quality and vigilance teams should log the notice and record any follow-up under their field safety corrective action 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.

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