BfArM - Federal Institute for Drugs and Medical Devices

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Date Title:
07.08.2025 Urgent Field Safety Notice for Allura Xper by Philips Medical Systems Nederland B.V.

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 36163/25

07.08.2025 Urgent Field Safety Notice for Philips Allura and Azurion by PHILIPS HEALTHCARE FRANCE

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 35351/25

07.08.2025 Urgent Field Safety Notice for Double loop ureteral stent kits by Coloplast A/S

Product group Non-active implants - special implants
Reference 34866/25

07.08.2025 Urgent Field Safety Notice for Agilia Connect VP by Fresenius Kabi AG

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 32960/25

07.08.2025 Urgent Field Safety Notice for Medihoney by Derma Sciences, inc (in process in transitioning to Acell)

Product group Dressings / Pads - ointments and gels
Reference 36948/25

06.08.2025 Thalidomide, lenalidomide and pomalidomide: Requirements for the prescription in Germany

Active substance: thalidomide, lenalidomide, pomalidomide The Federal Institute for Drugs and Medical Devices (BfArM) once again draws attention to the applicable safety regulations and the requirements for the proper prescription of thalidomide, lenalidomide and pomalidomide.

06.08.2025 Urgent Field Safety Notice for Poseidon S. Endplate 20x43mm 5° by Signus Medizintechnik GmbH

Product group Non-active implants - bone surgery
Reference 36259/25

06.08.2025 Urgent Field Safety Notice for SpeedControl Dial used with the Smartdrive MX2+ by MaxMobility LLC, Lebanon

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 35546/25

05.08.2025 Incident report

Incident report
05.08.2025 Urgent Field Safety Notice for SKULL TRACTION TONG LARG by Aesculap AG

Product group Medical instruments for use in humans - general instruments
Reference 35484/25

05.08.2025 Urgent Field Safety Notice for Caphosol Mundspülung by Recordati Netherlands B.V.

Product group Physical therapy - hydrotherapy
Reference 26699/25

05.08.2025 Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc.

Product group Optics / Precision engineering - laser technology
Reference 19922/25

05.08.2025 Urgent Field Safety Notice for imagiQ3 Legacy by Stille AB

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 27361/25

05.08.2025 Digital mailbox and digital notification consent

The new application "Digital mailbox" is available for pharmaceutical companies since 05.08.2025.
05.08.2025 Frequently asked questions

FAQ
04.08.2025 Urgent Field Safety Notice for medin-NC3 by medin Medical Innovations GmbH

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 33939/25

04.08.2025 Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V (as of 4 August 2025)

Reserve antibiotics: Exemption from the benefit assessment by standardized criteria according to §35A social code book (SGB) V
01.08.2025 Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA

Product group Active implantable medical devices - artificial hearts
Reference 23743/25

01.08.2025 Urgent Field Safety Notice for BD Vacutainer® ProntoT Quick Release Needle Holder by Becton Dickinson and Company, Franklin Lakes

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 29512/25

31.07.2025 Urgent Field Safety Notice for Citra-Lock S 4% by Sterisets Medical Products

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 33610/25