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14,962 results

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Urgent Field Safety Notice for CASE / CardioSoft Cardiac Testing System by GE Medical Systems Information Technologies PDF, 225KB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11820/21

Urgent Field Safety Notice for fabian HFO, +nCPAP evolution and Therapy evolution by Acutronic Medical Systems AG PDF, 281KB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 08040/21

Urgent Field Safety Notice for Jelonet (5 cm x 5 cm) "EurimPharm" by Smith & Nephew Medical Ltd. PDF, 1MB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 11321/21

Urgent Field Safety Notice for Dimension Vista High Sensitivity Troponin I Flex by Siemens Healthcare Diagnostics Inc. Newark PDF, 1MB, File does not meet accessibility standards Date: 21. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11705/20

URGENT: FIELD SAFETY NOTICE Philips Respironics CPAP and Bi-Level PAP Devices PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11652/21

URGENT: FIELD SAFETY NOTICE Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11651/21

Urgent Field Safety Notice for VivaDiag SARS-CoV-2 Ag Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. PDF, 96KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05458A/21

Urgent Field Safety Notice for Anse sterili per inoculazione by APTACA S.p.A. PDF, 369KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08902/21

Urgent Field Safety Notice for Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System by Medtronic CoreValve, LLC PDF, 187KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 11768/21

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 42KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10300/21

Urgent Field Safety Notice for Sabouraud 2 agar (SAB2-T) by bioMérieux S. (Marcy- l'Etoile) PDF, 668KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10319/21

Urgent Field Safety Notice for DiGeorge/VCFS N25 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 44KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10528/21

Urgent Field Safety Notice for DiGeorge/VCFS TUPLE1 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 123KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10527/21

Urgent Field Safety Notice for Randox NEFA (Non-esterified fatty acid) by Randox Laboratories Ltd PDF, 221KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10018/21

Urgent Field Safety Notice for Atellica CH 930, IM 1300, IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 76KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09937/21

Urgent Field Safety Notice for Creatine Kinase-MB (CK-MB) by Beckman Coulter Ireland Inc. PDF, 141KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10068/21

Urgent Field Safety Notice for Freelite Human Kappa Free Kit on Roche Cobas by The Binding Site Group Limited PDF, 268KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10064/21

Urgent Field Safety Notice for E2A (TCF3) Breakapart by Cytocell Ltd PDF, 45KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10549/21

Urgent Field Safety Notice for TCL1 Breakapart Probe by Cytocell Ltd PDF, 43KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10529/21

Have other EU Member States carried out a recall of PIP implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The European Commission has been informed by France and strongly advises the competent authorities of other EU Member States, warned by Afssaps, to take all useful and necessary measures in order to verify the involved implants are no longer …