BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Reporting Recalls

Field Safety Corrective Actions (FSCA)

FSCA Report Form for manufacturers (Initial, Final and Follow-up) according to Article 87 section 8 Regulation (EU) 2017/745 or Article 82 section 8 Regulation (EU) 2017/746

If PDF documents cannot be viewed with Firefox, please save locally or click here.
Please note our privacy policy (text in German language).

Measures taken by manufacturers

Customer information contains information from manufacturers about recalls of medical devices carried out on their own responsibility.

Customer information on manufacturer measures