Quality & complianceOfficial

BfArM publishes urgent field safety notice for AMOR Gummiwaren condoms across several models

🇩🇪 BfArM field safety notices · Wed 11 Nov 2026

Germany's medicines and devices authority has posted a manufacturer field safety notice for various AMOR Gummiwaren condom models, with details held only in the attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 11 November 2026 concerning condoms made by AMOR Gummiwaren GmbH. The notice covers several models, which the listing describes as "diverse Modelle", and is filed under the product group contraception – condoms.

BfArM's entry carries the reference number 51356/26. The page itself is brief and gives no description of the problem, the affected models or batches, or the actions the manufacturer is asking of customers.

Those details are contained in the manufacturer's advisory notice, which BfArM has attached as a 314 KB PDF. The authority directs readers to that document for further information and for details of the device.

Condoms are regulated as medical devices. A field safety notice is the formal communication a manufacturer sends to users or distributors when it takes a corrective action in the field, and national authorities such as BfArM publish these notices for transparency.

What it means for your team

  • Distributors, pharmacies, wholesalers and retailers handling AMOR Gummiwaren condoms should read the attached manufacturer notice to establish which models and batches fall within scope.
  • Quality and vigilance teams cannot judge the nature or severity of the issue from the BfArM listing alone; the PDF is the only source for the defect and required actions.
  • Teams should check stock and supply records against reference 51356/26 and follow the manufacturer's instructions once the scope is confirmed.

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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