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Recall for the PiCCO catheter, PULSION Medical Systems SE PDF, 138KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04243/15

Corrective action for the Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System, Siemens Healthcare Diagnostics PDF, 24KB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 04142/15

Corrective action for the products Genium, Genium X3, Otto Bock Healthcare Products GmbH PDF, 2MB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 04395/15

Recall of certain lots of Magic3™ Hydrophilic-coated Female Intermittent Catheter products, Rochester Medical Corporation PDF, 615KB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04345/15

Safety Notice concerning NDI Disposable Reflective Marker Sphere, Northern Digital Inc. PDF, 412KB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - special surgical instruments
Reference 04089/15

Recall for the Perfectum Tuberculin Glass Syringe & Micro‐Mate Tuberculin Glass Syringe, Cadence Science, Inc. PDF, 308KB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 04225/15

Corrective action for the Relax wall mounted shower seat, Etac Supply Center AB PDF, 196KB, File does not meet accessibility standards Date: 22. July 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 04232/15

Corrective action for the AKITA JET and AKITA² APIXNEB inhalation systems manufactured by Vectura GmbH (former Activaero GmbH) PDF, 912KB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 04147/15

Corrective action for the da Vinci® Xi™ Surgical System Draping, Intuitive Surgical PDF, 219KB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04263/15

Safety Information for certain GlideScope GVL® and AVL Reusable Laryngoscope Blades, Verathon Medical (Canada) ULC PDF, 192KB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 04100/15

Safety Information for the ACUSON S2000, S3000 with virtual touch IQ option, Siemens Medical Solutions USA, Inc./Ultrasound Business Unit PDF, 4MB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04159/15

Recall for the TransWarmer® Infant Transport Mattress, CooperSurgical PDF, 135KB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 04157/15

Folgeinformation VIDAS®3, bioMérieux PDF, 105KB, File does not meet accessibility standards Date: 21. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 07117/14

Urgent Safety Notice for the TruCal Lp (a) 21 calibrator, DiaSys Diagnostic Systems PDF, 2MB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04141/15

Recall for the Acumed 1.5 mm & 2.3 mm MultiScrew Depth Gauges, Acumed LLC PDF, 29KB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04208/15

Synthes GmbH: Corrective action for the product Locking Screw Diameter 3.5mm, Length 14mm PDF, 3MB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04139/15

Corrective action for the Hudson RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube, Teleflex Medical PDF, 109KB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03438/15

Urgent Safety Notice for the ACUSON S Family ultrasound systems, Siemens Medical Solutions USA, Inc./Ultrasound Business Unit PDF, 6MB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04172/15

Corrective action/Recall for the TFNA Helical-Blade Impactor, Synthes GmbH PDF, 3MB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03979/15

Corrective action for the RayStation 4.7, RaySearch Laboratories AB PDF, 165KB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 03596/15

Recall for the product ala® octa, alamedics GmbH & Co. KG PDF, 814KB, File does not meet accessibility standards Date: 20. July 2015 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - other medical devices for ophthalmological purposes
Reference 04113/15

Recall regarding the 23 mm Engager™Transcatheter Aortic Bioprosthesis, Medtronic 3F Therapeutics, Inc. PDF, 112KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 04162/15

Corrective action / Recall of several batches of SURESHOT Humeral 3.2 MM AO Drills, Smith & Nephew Inc. PDF, 74KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04329/15

Safety Notice for the product BRAHMS PCT direct, BRAHMS GmbH, part of Thermofisher Scientific PDF, 3MB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03501/15

Corrective action for the product iPlan RT Dose version 4.0 and 4.1, Brainlab AG PDF, 573KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04179/15

Corrective action for the Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems, GE Healthcare PDF, 144KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04140/15

Safety Notice for the ACUSON S1000, ACUSON S2000, or ACUSON S3000 ultrasound systems, Siemens Medical Solutions USA, Inc./Ultrasound Business Unit PDF, 6MB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04143/15

Corrective Action Ceiling Supply Unit klinoPORT, TRUMPF Medizin Systeme GmbH + Co. KG PDF, 538KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04121/15

Corrective action for the T-Lok™ Bone Marrow Biopsy products, Argon Medical Devices, Inc. PDF, 131KB, File does not meet accessibility standards Date: 15. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04010/15

Corrective action for the S3 Fluid Packs and S2 Fluid Packs (transponder defect), Roche Diagnostics PDF, 99KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03295/15