Data catalog
International device safety notices
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Continuing the International device safety notices list, 1000 records per page.
- Recall of 8-Rod Covers (Lot. No. 1104624, 1105182) due to manufacturing errors, QIAGEN
- Urgent Field Safety Notice for N Latex CDT OPCS by Siemens Healthcare Diagnostics Products…
- Recall MAS CardioImmune XL, Thermo Fisher
- Urgent Field Safety Notice for Carescape One by GE Medical Systems Information…
- Urgent Safety Notice for the Neptune® 2 Docker (STRYKER NEPTUNE® 2 WASTE MANAGEMENT…
- Urgent Safety Notice for Piezo Surgery Units Type “Piezomed SA-320”, W&H Dentalwerk…
- d70d66c9-36ba-ad01-c7c7-15329cff232d
- Recall for HUDSON RCI® Nebulizer Adaptor, Teleflex Medical
- Recall for all 7-french-Endoprosthesis of old material (light blue), Wieser Medizintechnik…
- Urgent Field Safety Notice for RM Classic reaming shaft, flex. 3rd gen. by Mathys AG…
- Urgent Field Safety Notice for Giraffe Shuttle by Datex-Ohmeda, Inc
- Recall for certain HLS Cannulae, MAQUET
- Urgent Field Safety Notice for Soft Tissue Punch by Omnia s.r.l
- Important Safety Notice for ECHELON ENDOPATH™ Endoscopic Linear Cutter Reloads, Ethicon…
- Urgent Field Safety Notice for Olympus by KeyMed (Medical & Industrieal Equipment Ltd.)
- Recall for Guide Wire Semislip, Urotech GmbH
- Urgent Field Safety Notice for Guiding catheter by BALT Extrusion
- Urgent Safety Notice for several Blood Glucose Monitoring Systems, Nipro Diagnostics
- Field Safety Notice for Flexi-Slip™ Endotracheal Tube Stylet, Teleflex Medical
- Urgent Field Safety Notice for BK Virus R-gene Real-time by bioMérieux S. (Marcy…
- Recall for MIRS Polyaxial Screw Body and MIRS Locking Cap, SYNTHES
- Lot Recall for the Profemur® AM Stem Ti Plasma, Wright Medical Technology Inc.
- Safety Notice for the ACUSON SC2000 ultrasound systems, Siemens Medical Solutions USA…
- Urgent Field Safety Notice for Revolution CT by GE Medical Systems LLC
- Recall of CLINITEST hCG kit, Siemens Healthcare
- Corrective Action of MEE-1000A Neuromaster, Nihon Kohden
- Recall for aixstent Oesophagus, Leufen Medical GmbH
- Urgent Field Safety Notice for Body Weight Support (BWS) Light by Motek Medical B.V
- Urgent Safety Notice: Recall of Aquavent Heated Ventilator and CPAP Breathing Circuits…
- Safety Notice for the Clinac, Trilogy, Novalis Tx and Unique jaw carriers, Varian medical…
- Urgent Safety Notice for the Kryptonite bone cement, DOCTORS RESEARCH GROUP
- Corrective action for Precision 500D X-ray imaging systems with CRT monitor suspension, GE…
- Field Safety Notice concerning Meducore Standard Defibrillator Monitoring System, Weinmann…
- Lot Recall of a TEP inlay, Stryker
- LIAISON Control Direct Renin
- Safety Notice concerning Definium 8000 and Discovery XR650 systems, GE Healthcare
- Urgent Safety Notice for the Samaritan PAD SAM 300/300P public access defibrillators…
- Field Safety Notice concerning surgical lights model Hanaulux G8, Maquet S.A.S.
- Corrective action for the ARCHITECT Total T3 Reagent Kit, Abbott
- Urgent Field Safety Notice for Accelerate Pheno system by Accelerate Diagnostics, Inc.
- Recall of Primary Antibodies to CD4 (clone 1F6), CD7 (clone LP15), Estrogen Receptor…
- Intera, Achieva and Panorama HFO MR systems All Models with Basic Triggering Unit and all…
- RayStation
- Scanbed 755
- Silica Substrate APTT Silica
- C-MAC
- Mifegyne 200mg tablets – Changes to prescribing information
- Silicone 2 way Foley Catheter Kit, 16Fr., Open Tip, Standard
- Variant II Hemoglobin Testing System
- Philips HaemoSphere R4.1
- 10MM FLEXTUBE NEONATAL RESUSCITATION BREATHING SYSTEMS
- Gyrus ACMI, Inc. Instaclear Sheath - plaadi purunemine distaalses otsas
- Signia Power Handle
- PROSET MULTIPACK SYRINGES
- Axxess^
- Soft suction liner
- VICI and VICI RDS Venous Stent systems
- DxC 500i Clinical Analyzer
- Raymat AS1
- Intellivue Information Center iX
- ad66208d-7118-218a-373b-55f8bce0ce18
- 17639ad1-ef59-f796-66fa-3e0df0c1e932
- Proximate pph Hemorrhoidal Circular Stapler, Model/Catalog PPH03
- Cascadia Interbody System
- 6a21ad99-275f-c2ab-f6a4-727f72b77a41
- Cannula venous
- DENTASEPT SH PRO WIPES
- NaviStar RMT DS Catheter
- T-flex Aspheric
- Suction Catheters
- Alinity s System
- Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems
- Rollator Nexus 50
- Artis Zee
- Exelia SP
- Philips Azurion system
- RA-74001 0.5 Micron Hydrophobic Disc Filter
- Urgent Safety Notice for Volumed µVP7000 and Syramed µSP6000 Infusion Pumps, Arcomed
- Urgent Field Safety Notice for Redcord Axis by Redcord AS
- Lot recall of acti-fine spine-ject spinal needle pencil point 26 G x 3 1/2 inch / 0,45 x…
- Urgent Field Safety Notice for LactoSorb RapidFlap by Biomet Orthopaedic LLC
- Lot recall of SYNCHRON Systems Multi Calibrator Diskette, Beckman Coulter
- Urgent Field Safety Notice for WATO EX-65, WATO EX-55, A5 and A7 by SHENZSHENZHEN MINDRAY…
- MEDICAL DEVICE FIELD SAFETY NOTIFICATION Anspach G1 Dissection Tools, Synthes GmbH
- Urgent Field Safety Notice for Ergo Just Cart by Natus Medical Incorporated DBA Excel-Tech…
- Safety Notice for the Axio Lab.A1 microscope, Carl Zeiss Microscopy GmbH
- Urgent Field Safety Notice for GELITA ENT X-PAND / GELITA-SPON RAPID by GELITA MEDICAL…
- Urgent Field Safety Notice for DR-XD 1000 / FDR Nano by FUJIFILM Corporation
- Recall of Intra Mobile Base, Planmeca
- Urgent Safety Notice for Tosoh Automated Glycohemoglobin Analyzers, Tosoh Corporation
- Safety Notice for GE OEC Fluorostar 7900, GE Healthcare
- Urgent Safety Notice for the Neuro Omega system, Alpha Omega Engineering Ltd.
- Recall for Disposable paper filter for sterilization containers, Stryker Leibinger GmbH &…
- Urgent Field Safety Notice for SONIC MICROCATHETER by BALT Extrusion
- Lot recall of Antimicrobial Susceptibility Testing Discs AMC30 Amoxycillin / Clavulanic…
- Safety Notice for the Mobile Detector Holder for Digital Diagnost X-ray systems, Philips
- Urgent Safety Notice for the BIRMINGHAM HIP Modular Head, Smith & Nephew
- Recall of Companion 2 Drivers, Syncardia Systems
- Recall for Bard DuaLok Breast Localisation Wire - Exposed Wire, Bard Peripheral Vascular…
- Field Safety Notice concerning corrective action of software CARINAsim and CARINAiso for…
- Urgent Safety Notice for the Cuff Controller (Shiley Pressure Control), VBM Medizintechnik…
- Urgent Field Safety Notice for VACUETTE Tube 2 ml 9NC Coagulation sodium citrate 3.2% by…
- Recall for the Portico™ Re-Sheathable Transcatheter Aortic Valve System, St. Jude Medical
- Urgent Field Safety Notice for Reagena POC PUUMALA lg by Oy Reagena Ltd
- Recall for the product Genu Arexa, Otto Bock HealthCare GmbH
- Discovery MR750w
- Recall for the EDS 3™ CSF External Drainage System, Codman Neuro
- Urgent Field Safety Notice for Swan-Ganz True Size Flow-Directed Monitoring Cat. by…
- Urgent Field Safety Notice for BALLARD Oral Care Swabs by Avanos Medical Inc
- Corrective Action for Dimension Vista Systems Software Version 3.4, Siemens
- Corrective action for the Covidien Medi-Trace™ Cadence Adult Multi-Function Defibrillation…
- Lot recall of Handi-Fill Disposable Syringe Fill Tube, article 302050MKG, Covidien
- Safety Notice concerning Brilliance CT 6, 16, MX8000 v. EXP and Gemini Dual systems…
- Urgent Field Safety Notice for ADVIA Centaur Calibrator 30 by Siemens Healthcare…
- Safety Notice for the Eclipse Treatment Planning System, Varian medical systems
- Lot recall of locking screws Stardrive Ø 2.4 mm / self-tapping / length 12 mm /…
- Urgent Field Safety Notice for Legacy Implant Closed - Tray Transfer-Concave by Implant…
- Corrective action for the Elecsys 2010 analyzer (Software Version 06-07 or below), Roche…
- Field Safety Notice regarding Vital Signs enFlow IV Fluid Warmer Model 100, GE Healthcare
- Important Safety Notice for the WATCHMAN Left Atrial Appendage Closure Device with…
- Recall concerning wire with bayonet point, Ilizarov ring fixator; possible problems during…
- Urgent Safety Notice for the Digital Radiography X-Ray Systems DR 400, Agfa Healthcare…
- Safety Notice concerning several models of SlingBars, Liko GmbH
- Corrective action for the Alaris™ CC, GH, GS, PK and TIVA Syringe pumps, CareFusion
- Urgent Field Safety Notice for Tapered Screw-Vent MTX by Zimmer Dental Inc.
- Urgent Field Safety Notice for ARCHITECT S.A. Myoglobin Reagent Kit by Abbott Laboratories…
- Urgent Field Safety Notice for Replant 5.0mmD Abutment Assy 15 deg Angled by Implant…
- Urgent Field Safety Notice for Abdominal retractor, self-retaining, fixed by Ulrich GmbH &…
- Lot recall of Whipknot Soft Tissue Cinch #5 Sutures, Smith & Nephew Inc.
- Potential failure of Hot air sterilisers SNE / SFE / SFP 200-800, Memmert GmbH + Co. KG
- V60 Ventilator
- Recall for the Actifuse ABX, Actifuse MIS System and Inductigraft products, Baxter…
- Urgent field safety notice for O-arm 1000 and O-arm O2 Surgical Imaging System, Medtronic
- Lot recall of OptEase retrievable vena cava filters (articles no. 466F210A und 466F210B)…
- Urgent Product Recall for the PillCam® Express Delivery Devices, Given Imaging
- Urgent Field Safety Notice for V60 / V60 Plus / V680 by Respironics California, Inc.
- Urgent Safety Notice for the ADM®/MDM® Ball Impactor Tip and ADM® RIM Impactor Tip…
- Urgent Field Safety Notice for Implant Inserter S. Connection by EIT Emerging Implant…
- Corrective action for the Hudson RCI® Paediatric Anaesthesia Breathing Circuit, Teleflex…
- Lot Recall of the Carotis Sets, Mölnlycke Health Care
- Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
- Urgent Field Safety Notice for Extremity Pack by Medline International France SAS
- Recall of one lot of Mini-Redon Pump-Sets, Dahlhausen
- Urgent Field Safety Notice for SCHILLER CARDIOVIT AT-102 plus by Schiller AG
- Safety Notice concerning the Power Wheelchair “B400“ with ISO-Set and the ISO-Set, Otto…
- Urgent Field Safety Notice for cobas e 411 und Elecsys 2010 analyzer (jeweils disk+ rack…
- Urgent Safety Notice for the product m24sp, Abbott Molecular Inc.
- Urgent Field Safety Notice for ORAcollect DNA / ORAcollect RNA / ORAcollect Dx by DNA…
- Safety Notice concerning a corrective action of the external defibrillators Samaritan PDU…
- Recall for the OffRoad™ Re-Entry Catheter System, Boston Scientific
- Urgent Field Safety Notice for ThermoShield Neonatal HME by Flexicare Medical Limited
- Urgent Field Safety Notice for EVOSET AFB K+ INFUSION, CARTRIDGE WITH HEMOSCAN, AR by…
- Urgent Field Safety Notice for PAS-PORT PROXIMAL ANASTOMOSIS DEVICE by Aesculap AG
- Recall for TRANSRADIAL ARTERY ACCESS KITS, Arrow International Inc.
- Recall of the product Urgo Aphthen, Urgo GmbH
- Urgent Field Safety Notice for PERFUSION TUBING SYSTEMS by Sorin Group Italia S.r.l.
- Batch recall of twinSys double offset adaptor, Mathys Ltd. Bettlach
- ARTIS Icono Biplane
- Alinity i Free T3 & Total T3 Reagent Kits
- CR 975
- Urgent Field Safety Notice for ACE MDI Spacer with Small Mask by Smiths Medical ASD, Inc…
- Urgent Field Safety Notice for Brilliance iCT, Brilliance iCT S., IQon Spectral C by…
- Safety Notice concerning MX 16-Slice CT systems, Philips
- Another Safety Notice for the NOVO X 550 Dialysis Bed Chair, Likamed GmbH
- Urgent Field Safety Notice for mylife OmniPod Insulin Management System
- Urgent Field Safety Notice for recomWell Helicobacter IgA by Mikrogen GmbH
- Urgent Field Safety Notice for xevonta Lo 18, xevonta Hi 18, xevonta Hi 20 by B. Braun…
- Safety Notice concerning Brilliance CT Big Bore with software versions 2.4.7 and 2.4.8…
- Safety Notice for the product MOSAIQ, Elekta
- Refobacin Bone Cement, Refobacin Plus Bone Cement, Refobacin Revision
- Urgent Field Safety Notice for LEGIONELLA-M.W.Y.-SELEKTIVNÄHRBODEN by Oxoid Deutschland…
- Field Safety Notice Odalys sterile rods
- Sampling Site Connector
- Safety Notice for the mobile digital radiography system MobileDiagnost wDR, Philips…
- Urgent field safety notice for Operating Table Tops for Modular Exchangeable Table Top…
- Urgent Field Safety Notice for Fabian HFO / HFOi by Acutronic Medical Systems AG
- Safety Notice for Peregrine Surgical Peeler Forceps, Peregrine Surgical Limited
- Urgent Safety Notice for the Pinnacle Treatment Planning System, Philips Healthcare
- Urgent Field Safety Notice for AQURE system by Radiometer Medical ApS
- Lot Recall of BD Venflon Obturator 20GA, Becton Dickinson
- Urgent Field Safety Notice for Nexus KIS Medikationsmodul by NEXUS / DIS GmbH
- Urgent Field Safety Notice for DigitalDiagnost by Philips Medical Systems DMC GmbH
- Safety Notice for the KIMVENT* Closed Suction Systems, Halyard Health
- incarePORT
- Important Safety Notice for the MultiDiagnost Eleva with Flat Detector system, Philips…
- Urgent Field Safety Notice for BacT/ALERT BPN Culture Bottle by bioMérieux Inc
- Corrective action for the Calcitonin ELISA Kit, Biomerica
- Corrective action of the HeartStart XL (M3735A) Defibrillator/Monitor battery M3561A…
- Corrective action for Vitros Immunodiagnostic Products CA 125 II Calibrators, Ortho
- Urgent Field Safety Notice for Philips PageWriter TC Cardiographs (TC20/30/50/70) by…
- Brainlab Spine & Trauma 3D Navigation 1.0 (subpart of the system “Navigation Software…
- Batch recall of surgical sutures Seralon, Seraflex, Supramid and Terylene, Serag-Wiessner
- Corrective action for XN-Series analysers, Siemens
- Urgent Field Safety Notice for Ovation iX by Endologix International Holdings B.V.
- Urgent Field Safety Notice for DLP product divers by Medtronic Inc
- Urgent Field Safety Notice for HeartStart XL by Philips Medical Systems
- Urgent Field Safety Notice for Rusch TracFlex Plus Set, cuffed, TracFlex Plus PDT Set…
- Corrective action for the GMK Intramedullary Extension Rod 100 mm, Medacta International…
- Urgent Field Safety Notice for RüschCare TracFlex Plus Tracheostomy Tube with Subglottic…
- Urgent Field Safety Notice for Centricity High Acuity Critical Care by GE HEALTHCARE…
- Corrective action for Artis zee and Artis zeego systems, Siemens AG Healthcare Sector
- URGENT FIELD SAFETY NOTICE for BD Vacutainer® Eclipse TM Signal™ Blood Collection Needle…
- Corrective action for Artis zeego systems, Siemens AG
- Urgent Field Safety Notice for QUADROX-i Neonatal Microporous Membrane Oxygenator by…
- Urgent Field Safety Notice for Leica M320 F12 by Leica Microsystems (Schweiz) AG
- Urgent Field Safety Notice for Orchestra Base Intensive and Orchestra Base Primea by…
- Urgent Field Safety Notice for TruSystem 7500 by TRUMPF Medizin Systeme GmbH + Co. KG
- Urgent Field Safety Notice for Efficia 3/5 ECG Trunk Cable, AAMI/IEC by Philips Medical…
- Urgent Field Safety Notice for Thermo Scientific Oxoid BiGGY Agar _ CM0589B by Thermo…
- Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
- Corrective action for Varimed - Height adjustable examination and treatment couch, Schmitz…
- Urgent Field Safety Notice for Optima CT 660, Revolution EVO by GE Healthcare Japan…
- Urgent Safety Notice for the stereo biopsy devices for MAMMOMAT Inspiration mammography…
- Urgent Field Safety Notice for Zenition 50, Zenition 70 Systems by Philips Medical Systems…
- Urgent Field Safety Notice for MERLIN PROGRAMMER by S.. Jude Medical CRMD
- Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook…
- Urgent field safety notice for Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector…
- Urgent Field Safety Notice for ABL800 with FlexQ by Radiometer Medical ApS
- Recall for L2 poly liner, SMR Shoulder System, Limacorporate
- Lot recall of mini²SKY gingiva former, bredent medical GmbH & Co. KG
- Urgent Field Safety Notice for compass 530 Haltungs- / Bruststabilisator by Proxomed…
- Lot recall of Angel Blood Access Kit, Citra Labs / Nuo Therapeutics (Cytomedix Inc.) /…
- Urgent field safety notice for Cytoluer, Baxter International Inc.
- Urgent Field Safety Notice for DRYSTAR DT 10 B, DRYSTAR DT2B and DRYSTAR DT 2 B by Agfa…
- Urgent Field Safety Notice for Microstream Advance and Microstream Luer Sampling Lines by…
- Urgent Field Safety Notice for PentaRay NAV Catheter by Biosense Webster, Inc. (Diamond…
- Urgent Field Safety Notice for EVIS EXERA(Q190V)-/LUCERA(Q290V) DUODENOVIDEOSCOPE by…
- Urgent Field Safety Notice for BD BodyGuard MicroSet by Caesarea Medical Electronics Ltd.
- Urgent Field Safety Notice for ReoAmbulator by Motorika Medical (Israel) Ltd.
- Urgent Field Safety Notice for CLIMBER by PendraCare International B.V.
- Urgent Field Safety Notice for Safe Cut, Bone Marrow Marrow Cut, MR Safe Cut by Somatex…
- Urgent Field Safety Notice for Coherex WaveCrest Left Atrial Appendage Occlusion System by…
- Important Safety Notice for the XiO RTP System, IMPAC Medical Systems, Inc.
- Urgent Field Safety Notice for Monoclonal Mouse Anti-Human Cytokeratin, High Mole by Dako…
- Urgent Field Safety Notice for Bil. Auto Dir.;Bil. Auto Total; Cre. mod. Jaffe by DIALAB…
- Carestation 620, Carestation 650, Carestation 650c
- MOSAIQ
- Urgent field safety notice for Fixture 1002.65A0, MAQUET GmbH
- Urgent Field Safety Notice for SYMPHONY/RHAPSODY by MicroPort CRM S.r.l.
- Product Discontinuation for the AcrySof® CACHET® Phakic Lens, Alcon
- Urgent Field Safety Notice for Mycoplasma genitalium Control Panel by Microbiologics, Inc.
- Lot recall of RUSCH-Catheter for radiation measurement, Teleflex Medical
- Urgent Field Safety Notice for OLYMPUS-DISPOSABLE GRASPING FORCEPS by Olympus Medical…
- Safety Notice for Brivo OEC 715/785/865 C-Arm systems, GE Healthcare
- Recall for the Aliquot Delivery Kits (Syringe and Plunger), Stryker® Orthobiologics
- Recall of Allura Xper R8.2 and UNIQ R1.0 X-ray Systems, Philips Image Guided Therapy…
- Corrective action for the Philips Expression Information Portal (IP5), Philips Medical…
- Urgent Field Safety Notice for AstraT, AzureT, PerceptaT, SerenaT, SolaraT by Medtronic…
- Urgent Safety Notice for the Medi-Trace™ Cadence and Kendall™ Defibrillation Electrodes…
- Urgent Safety Notice for the Calcitonin ELISA, IBL International GmbH
- Safety Information for the Zimmer Trilogy® Acetabular System Shell without Holes, Zimmer…
- Installing a second EO Sensor for Low Temperature Sterilizer, DMB Apparatebau GmbH
- Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.
- Safety Notice for Dash 3000/4000/5000 patient monitor, GE Healthcare
- I-PRF Tubes
- Recall for the product ProcedurePak®, Mölnlycke Health Care
- Urgent Field Safety Notice for Lantis Commander oder Lantis System by Siemens AG…
- Urgent Field Safety Notice for FTD Stool parasites by Fast-Track Diagnostics S.a.r.l.
- Urgent Safety Notice for the BeneHeart D1 Defibrillator/Monitor, Shenzhen Mindray…
- Urgent Field Safety Notice for CELL-DYN Emerald; Emerald Diluent Tubing by Abbott…
- Recall for the Cancellous Bone Impactor, Synthes GmbH
- Urgent Field Safety Notice for Unyvero P55 Pneumonia Cartridge Set by Curetis GmbH
- Recall for the Expert Tibial Nail Protect, SYNTHES
- Urgent Field Safety Notice for Olympus KeyMed OFP-2 Flushing Pump Accessory- MAJ-1606…
- Corrective Action for IMMULITE / IMMULITE 1000 in combination with the IMMULITE…
- Urgent Field Safety Notice for AUTION HYBRID AU-4050 by Arkray Factory, Inc.
- URGENT FIELD SAFETY NOTICE for BD Affirm VPIII Microbial Identification Tests, Becton…
- Urgent Field Safety Notice for CTAD-Monovette by Sarstedt AG & Co
- Safety Notice for the Guide tube for segments and cervical sleeves, straight (a component…
- Urgent field safety notice for TIGR Matrix Surgical Mesh, Novus Scientific AB
- Urgent Safety Notice for the product Bone Level 4.1 mm RC SLActive 8 mm Roxolid Loxim…
- Urgent Safety Notice for the Medtronic CryoConsole, Medtronic
- Urgent Field Safety Notice for Anti-Gravity by AlterG, Inc.
- Urgent Field Safety Notice for Rim Platte, 10-Loch, Links, PRS RX System by I.T.S. GmbH
- Recall of Double Lumen Needles for Oocyte Retrieval, Origio A/S
- Urgent Field Safety Notice for Catalys System by AMO Manufacturing USA, LLC
- Lot Recall for ILLICO cannulated polyaxial screws, ALPHATEC SPINE
- Urgent Safety Notice for the Accu-Chek® Spirit Combo insulin pump, Roche Diagnostics…
- Urgent Field Safety Notice for AXIOM Artis/Artis zee by Siemens Healthcare GmbH Advanced…
- Corrective Action for LIAISON Control Mumps IgG, DiaSorin
- Urgent Field Safety Notice for Diverse Luer Lock Produkte by Trusetal Verbandstoffwerk…
- Lot recall of Columbia Blood Agar Base CM0331, Thermo Fisher Scientific / Oxoid Limited
- Lot recall of Sinaqua Dermal Glove / Sinaqua Wipe / Easyderm Glove, Welcare lndustries…
- Lot specific recall of the Trilogy® Acetabular System Shell with Cluster Holes, Zimmer…
- Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH
- Excel 23kHz Disposable Wrench
- ABL80 Flex analyzer
- Safety Notice concerning Mini C-arm models InSight2 and InSight FD, Hologic
- Corrective action for Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S…
- Urgent Field Safety Notice for IMTEC-CIC IgG ELISA by HUMAN Gesellschaft für Biochemica…
- Corrective action for the product Liaison® Tg, DiaSorin
- Recall of products packaged at the Toulon (France) facility, Wright Medical Technology
- Urgent Field Safety Notice for DuraDiagnost X-ray system, Philips Healthcare IS China
- Intramesh T1
- Lot recall of AcrySof IQ IOL with UltraSert Implantation System, Alcon Pharma GmbH
- Urgent Safety Notice for the power wheelchairs Invacare FDX, Invacare GmbH
- Urgent Field Safety Notice for Habib EndoHPB Bipolar Radiofrequency Catheter by Boston…
- Additional Safety Notice for the Interventional Wires and Attain Hybrid® Guidewires…
- Urgent Field Safety Notice for VNS Therapy AspireSR and AspireHC Generator by Cyberonics…
- Urgent Field Safety Notice for Artis, X-Workplace, Sensis and ARCADIS systems by Siemens…
- Urgent Field Safety Notice for Chocolat PolyViteX (PVX) by bioMérieux S. (Marcy- l'Etoile)
- Safety Notice for Dialox 10 kg, Bioxal SA
- Urgent Field Safety Notice for ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer by Radiometer…
- Urgent Field Safety Notice for EZ2 Connect MDx by QIAGEN GmbH
- Safety Notice for Dimension Vista 500 and Dimension 1500, Siemens
- Recall for the product CONTImove S version 2 - Power supply/charger, Buck Elektromedizin…
- Urgent Safety Notice for MATResponder Tourniquet, Pyng Medical Corp.
- Safety Notice for Liko® Bathing Chair, Liko AB
- Urgent Field Safety Notice for EliA Stool Extraction Kit by Phadia AB
- Recall of various kits containing ACDA, Zimmer Biomet
- Lot recall of Passeo-18 peripheral balloon catheter, Biotronik AG
- Urgent field safety notice for NobelParallel CC Guided Surgery Kit, Nobel Biocare
- TWINFIX SUTURE ANCHOR
- Device Correction of the Surgical Technique for the TM Ardis Inserter, Zimmer Inc.
- Corrective action for Zimmer® Universal Power System Handpieces, Zimmer Surgical SA
- Urgent Field Safety Notice for Yumizen H500 CT by HORIBA ABX SAS
- Recall for the ThruPort™ Knot Pusher Model KP1 and Valve Placement Pack Model VPP, Edwards…
- Urgent Field Safety Notice for Medfusion Model 3500; Medfusion Model 4000 by Smiths…
- Safety Notice for the Freka® Intestinal PEG-Tubes, Fresenius Kabi
- Urgent Field Safety Notice for EXCOR by Berlin Heart GmbH
- Urgent Field Safety Notice for Zementkanüle, Knochenzugangsnadel by Signus Medizintechnik…
- Urgent Safety Notice for the m2000sp Instrument Systems, Abbott Molecular, Inc.
- Lot recall of 1st Generation Axial Torque Limiting Driver, Bradshaw Medical Inc.
- Urgent Field Safety Notice for EVA Parenteral Nutrition Container (250ml) . EVA P by…
- Corrective action for the Enzygnost® Syphilis test plates, Siemens Healthcare Diagnostics…
- Urgent Field Safety Notice for Closed Suction System by Halyard Health Inc.
- Urgent Field Safety Notice for Symbia Intevo 6 and Symbia Intevo Bold by Siemens Medical…
- Urgent Field Safety Notice for ProSpecT STEC Shiga Toxin E. coli Microplate Assay by…
- Urgent Field Safety Notice for Titan Inflatable Penile Prosthesis by Coloplast A/S
- Urgent Field Safety Notice for SARS-COV-2 R-GENE and SARS-COV-2 RESPI R-GENE by bioMerieux…
- Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.
- Urgent Safety Notice for the Astral device, ResMed Ltd.
- Safety Notice for certain Engström Ventilators and Aespire View, Aisys, and Avance…
- Urgent Field Safety Notice for Niobe ES by Stereotaxis, Inc
- Important Information for the product IMPAX EE R20 Release XIII, Agfa HealthCare
- Urgent Field Safety Notice for EcoFit® 2M head Ø28/56mm, EcoFit 2M head Ø28/58mm by…
- Safety Notice for the Trinica® ALP-System, Zimmer Inc.
- Corrective Action for DELFIA/Auto / DELFIA Enhancement Solution, PerkinElmer
- Urgent Field Safety Notice for Sinapi Chest Drain by Sinapi Biomedical (Pty) Ltd
- Urgent Safety Notice for the orthopedic hip implant VarioFit Classic (cemented), Steinicke…
- Corrective Action for IMMULITE / IMMULITE 1000 / IMMULITE 2000 / IMMULITE 2000 XPI in…
- Field Safety Notice concerning MobileDiagnost wDR X-ray system, Philips
- Urgent Safety Notice for care beds Amara and Amara-Tero, Stiegelmeyer GmbH & Co. KG
- Corrective action for Ingenuity CT, Ingenuity Core and Ingenuity Core128 CT systems…
- Urgent Field Safety Notice for HINTEGRA & HINTEGRA SENSITIVE by Newdeal SAS
- Lot recall of Sterile RENASYS Transparent Film, Smith & Nephew Inc.
- Urgent Field Safety Notice for Mentype Chimera CE-IVD by Biotype Diagnostic GmbH
- Urgent Field Safety Notice for ADV ANSYS by Newdeal SAS
- Safety Notice concerning the Hand control of care bed model Westfalia-Klassik and bed…
- Safety Notice for STERRAD® NX 100, ASP (Advanced Sterilization Products)
- 837cd9f5-df2f-f413-1782-e82a96f058ae
- Voluntary Recall of Specific Serial Numbers of ConforMIS Knee Replacement Systems…
- Urgent Field Safety Notice for No. sterile pin guide by TORNIER SAS
- Corrective Action for ProTime3 Cuvettes, ITC
- Recall for QFT Gold Tubes, QFT Gold Tubes High Altitude (HA), QFT Gold Single Patient Pack…
- Safety Notice concerning the DEBAKEY Vascular Dilators, PRO-MED Instrumente GmbH
- Urgent Field Safety Notice for SECURODRAIN / NeuroVac Silikon-Flachdrainage by Neuromedex…
- Safety Notice for Elekta motorized wedges in RayStation 3.0, 3.5 and 4.0, RaySearch…
- Corrective Action for Accu-Chek Aviva Combo, Roche
- Urgent Safety Information regarding burrs, Richard Wolf GmbH
- Urgent Field Safety Notice for MOSAIQ by IMPAC Medical Systems, Inc.
- Corrective action for Vitros Chemistry Products Na+ Slides und Vitros Chemistry Products…
- Safety Notice for the Brilliance 64 and Ingenuity CT Scanners, Philips Healthcare
- Lot Recall for the Lifeshield, Latex-Free, Non-DEHP, Primary Plumset, Hospira
- Recall for the Biatain Ag Filler/Cavity Foam Dressing, Coloplast A/S
- Corrective action for Vitek MS, bioMérieux
- Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed…
- Urgent Field Safety Notice for ACUSON Juniper Diagnostic Ultrasound System by Siemens…
- Urgent Field Safety Notice for EZ1 DSP Virus Kit (48) by QIAGEN GmbH
- Urgent Field Safety Notice for ACUSON Redwood by Siemens Medical Solutions USA, Inc…
- Corrective Action for IMMULITE ACTH Control Module, Siemens
- Urgent Field Safety Notice for ACUSON Maple/Maple Select ultrasound system by Siemens…
- Urgent Field Safety Notice for MERLIN PROGRAMMER by S.. Jude Medical CRMD
- Important Safety Notice for Leksell Gamma Knife® Perfexion™ - stereotactic surgery system…
- 9f5c6d2b-8809-7ab5-1351-04e39961a9b7
- Urgent Field Safety Notice for Elecsys Digoxin by Roche Diagnostics GmbH
- Safety Notice concerning sat 805 and 816 pulse oximeters, Bitmos GmbH
- Recall for the LEXA® femoral components, C2F IMPLANTS
- Voluntary Recall of Anaconda™-ONE-LOK Bifurcate Body and Anaconda™ Bifurcate Body…
- Urgent Field Safety Notice for Hitachi by Hitachi, Ltd.
- Urgent Safety Notice for the Human IgG Kits for use on the Beckman Immage®, The Binding…
- Urgent field safety notice for Silver Tracheostomy Tubes, Phoenix Surgical lnstruments
- Urgent Field Safety Notice for Horizon/McKesson Cardiology Hemo by Change Healthcare…
- Urgent Field Safety Notice for using GE Healthcare 3.0T MR Scanners
- Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens…
- Safety Notice for the therascreen BRAF RGQ PCR Kit, QIAGEN
- Invivoscribe, Inc. LymphoTrack DX - Miseq - teatud partiide mittevastavus
- Urgent Safety Notice (Update) for the DBB-06/DBB-07 Hemodialysis Devices, Nikkiso
- Corrective action for Radiolucent Bone Lever Retractor, Synthes GmbH
- Urgent Field Safety Notice for DirectInject 5cc by Stryker Leibinger GmbH & Co. KG
- Urgent Field Safety Notice for COULTER LH 750, LH 780, LH 500, COULTER HmX CP,COULTER HmX…
- Urgent Field Safety Notice for Access Substrate by Beckman Coulter, Inc.
- Recall for Endotracheal tubes, Vygon
- Safety Notice for “Metal-finish” Lamp Modules on th da Vinci Si (IS3000) System…
- Lot Recall for the Guide Extension Epoca, Synthes GmbH
- lmportant customer safety notice for AXIOM Artis FA, FC, dFA, dFC, dFCM, AXIOM Artis BA…
- Corrective Action for QuantiFERON-TB Gold (QFT) Test, Quiagen
- Safety Notice for OsseoCare Pro iPad® app software release 1.2.0.7, Bien-Air Dental
- Urgent Field Safety Notice for Sonderangefertigtes Katheterisierungsset Coro-Set für GFO…
- Urgent Field Safety Notice for Tissu-Trans by Shippert Medical Technologies
- Safety Notice for Discovery NM/CT670, Optima NM/CT640, Discovery NM630 and Brivo NM615, GE…
- DEFIGARD TOUCH7
- da Vinci Xi Surgical System
- Ziehm Solo
- Medical surgical instruments: Harmonic HD 1000i scissors (shaft length 20 cm) (catalog…
- HistoCore Pegasus and HistoCore Pegasus Plus
- Corrective action for the APTUS temporary tension bolt, Medartis AG
- Urgent Field Safety Notice for DuraDiagnost by Philips Healthcare (Suzhou) Co.,Ltd
- Urgent Field Safety Notice for DYNASEAT by WINNCARE FRANCE
- Urgent Field Safety Notice for cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC, Roche
- Urgent Field Safety Notice for MX40 Intellivue by Philips Medical Systems
- Recall of the SynReam-Medullary Reamer Head, DePuy Synthes
- Urgent Field Safety Notice for 9733449 Straight Suction EM, ENT; et alii by Medtronic…
- Urgent Field Safety Notice for syngo® Lab Data Manager, Siemens Healthcare Diagnostics…
- f6c023cf-1d97-fa75-d006-210c7e097c7e
- Safety Notice for VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4…
- Recall for specific lots of LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium Femoral…
- Urgent Field Safety Notice for GLENOID COMPONENTS - OTHER by Lima Corporate S.p.A.
- 212de425-dd1f-29ef-e314-936f76913c72
- Recall of several batches of the product family Tissue-Guard (Vascu-Guard, Dura-Guard…
- Safety Notice for the DigitalDiagnost patient carriage, Philips
- Immunotech S.A.S. Access hsTnI Reagent Kit - ekslikult kõrgendatud tulemused cTnl…
- Lot recall of Cannulated Screw 3.5, aap Implantate
- Medical Device Recall for Sciatic Nerve Retractors
- Urgent Field Safety Notice for Perutaneous Introducer Sheath 7F and 8F by optimed…
- Urgent field safety notice for Ceiling Lift Altair, Roomer S and HeliQ, Human Care HC AB
- Medtronic Covidien DAR airway products - kasutamise peatamine, toodete steriilsus ei ole…
- Urgent Field Safety Notice for Heater Cooler Unit HCU 40 by Maquet Cardiopulmonary AG
- Urgent Field Safety Notice for BlueDot Gastritis IgG by D-tek SA
- Urgent Field Safety Notice for General Impactor by Stanmore Implants Worldwide Ltd
- Urgent Safety Notice for the FreeStyle Libre Flash Glucose Monitoring System, Abbott…
- Lot recall of OPTILENE 4/0 (1,5) 90 CM 2XHRC22, B. Braun Surgical S.A.
- Urgent field safety notice for ADVIA Chemistry XPT Systems, Siemens Healthcare Diagnostics…
- IMPORTANT FIELD SAFETY NOTICE, Dose and MU Incorrect, Product Monaco, Elekta
- Urgent Field Safety Notice for Heron by R82 A/S
- Recall for the flexible Drills D3,2 x 149, Exatech Deutschland GmbH
- Urgent Field Safety Notice for Oxford Dipper by Joerns Healthcare Ltd. Customer Services…
- Giraffe and Panda Warmer T-Piece Resuscitation System
- Urgent Field Safety Notice for Untersuchungsliege 4203.94 by Maquet GmbH
- Urgent Safety Notice concerning the material of tubing in dosage pump of miniETD2 PAA and…
- Urgent Safety Notice for SPIROTOME, biopsy instruments, Medinvents NV
- Field Safety Notice concerning Digital Linear Accelerators ONCOR and ARTISTE, Siemens…
- Urgent Field Safety Notice for Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified…
- Field Safety Notice concerning AEROcheck®sat 805 and AEROcheck®sat 816 pulse oximeters…
- Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc
- Urgent Field Safety Notice for Mentype® MycoDermQS Lateral Flow by Biotype Diagnostic GmbH
- Urgent Field Safety Notice for Philips-EPIQ and Affiniti Ultrasound system by Philips…
- Urgent Field Safety Notice for Vulcan Fast Red Chromogen Kit by Biocare Medical (Pacheco)
- Safety Notice for the Acuson X150 and Sonoline G40 ultrasound systems, Siemens
- Lot Recall for Intrafix Primeline / Intrafix Air P sets, B. Braun Melsungen AG
- Corrective action for the Anti-Leb, clone LEB2, CE-lmmundiagnostika GmbH
- Corrective action for the Cedia Tobramycin II Assay, Microgenics
- Lot Recall for the Tezo Titanium Cage, ULRICH GmbH & Co. KG
- Corrective action for Armstrong Medical Humidification Chambers and Breathing Circuits…
- Urgent Field Safety Notice for X-Cid2 by Micro-Mega
- Safety Notice for Surgical Kits about the change of sterilization instructions, BIOMET 3i
- Urgent Safety Notice for the TruSystem 5500 operating table system, TRUMPF Medizin Systeme…
- Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
- Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
- Urgent Field Safety Notice for My Therapy App for Sacral Neuromodulation Therapy by…
- Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH
- Urgent Field Safety Notice for ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics…
- Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
- Corrective action for the DPB1 SSP products, ThermoFisher Scientific
- Recall for MOSAICPLASTY™ Kits (MOSAICPLASTY DP - Disposable Harvesting System), Smith &…
- Safety Notice for the Brilliance iCT system, Philips Healthcare
- Corrective action for the ARCHITECT i2000SR System, Abbott
- Urgent Field Safety Notice for Kerrison St. DieBlauen by Medicon eG
- Corrective Action for the ABL90FLEX Analyzers, Radiometer
- Urgent field safety notice for DxH 500 (PN B40601), Beckman Coulter
- Urgent Field Safety Notice for Impactor Handle by Waldemar Link GmbH & Co. KG
- Safety Notice for ConMed Electrosurgery ALTRUS® Termal Tissue Fusion Handpieces (2 lots)…
- Urgent Field Safety Notice for N Antiserum to Human Ig/L-chain, LAMBDA-type by Siemens…
- Urgent Field Safety Notice for AIA-900 Analyzer by Tosoh Corporation
- Urgent Field Safety Notice for Asahi APS-H Series Hemodiafilter by Asahi Kasei Medical…
- Urgent Field Safety Notice for Mindray- ; Weinmann defibrillation electrodes by Leonhard…
- Field Corrective Action to patient chairs TENEO, Sirona Dental Systems GmbH
- Urgent Field Safety Notice for Analyzer (software) for FluoroType CDiff VER 1.0 by Hain…
- Gyrus One Piece Electrode
- COULTER Ac * TTM 5diff Cap Pierce Hematology Analyzer
- Corrective action for the Dolphin Inflation device - Caliber Inflation Device, Perouse…
- Safety Notice for the ON-Q Pump with ONDEMAND Bolus Button, Halyard Health, Inc.
- Corrective Action for CYFRA 21-1 KRYPTOR, Brahms
- Urgent Field Safety Notice for Olympus Diego Elite High speed drill burrs by Olympus…
- Safety Notice for the Liko® Sabina® and Capella™ Sit-to-Stand Mobile Lifts, Liko AB
- Recall for i-STAT PT/INR cartridge, Abbott
- Lot Recall of BD Oral Dispensing Syringes, Becton Dickinson
- Urgent Field Safety Notice for Tests based on NAD(H)/NADP(H) reaction, see ca..no by…
- Corrective Action for Elecsys Tg in combination with CalSet Tg Elecsys, Roche
- Urgent field safety notice for Laerdal Suction Unit (LSU) with LSU NiMH Battery, Laerdal…
- Urgent Safety Notice for the wheelchair model TMB, Trendmobil GmbH
- Corrective action for UniCel DxI Access Immunoassay System Software, Beckman Coulter
- Recall of Lipase Reagent, Randox Technical Services / Randox Laboratories Ltd.
- Urgent Field Safety Notice for OCTOPODA Rod, 5,5 x 50mm by Bricon GmbH
- Corrective action for the Pak12, Immucor GTI Diagnostics
- Lot recall of Lotus Valve System, Boston Scientific International S.A.
- Recall for Oxoid Yersinia - Selective Supplement, Oxoid
- Safety Notice concerning the Manual Film Composer Issue on Brivo CT315/325, Brivo CT385…
- Urgent Field Safety Notice for CAIMAN by Aesculap AG
- Urgent Field Safety Notice for balanSys Revision by Mathys AG Bettlach
- Urgent Field Safety Notice for Internal Sterilizable Defibrillator paddles by Philips…
- Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
- Urgent Field Safety Notice for Infusionsregler STAT2 by ACCURA Medizintechnik GmbH
- Urgent Field Safety Notice for Atellica and ADVIA Creatine Kinase (CK_L) Reagent by…
- Urgent Field Safety Notice for Sterilized Drape for PDE by Fuji Systems Corporation…
- Urgent Field Safety Notice for patient table (Ysio / Ysio Max / Multix Fusion), Siemens…
- Urgent Field Safety Notice for Phadia 1000 by Phadia AB
- Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
- Recall Offset Adapter A-642100, Össur
- Urgent Field Safety Notice for DRILL BIT MINI-QUICK CONNECT by Biomet Orthopaedic LLC
- Urgent Field Safety Notice for Remisol Advance v.1.12 by NORMAND INFO
- Corrective action for IMMULITE®/IMMULITE® 1000 Cortisol (LKCO1) assays, Siemens Healthcare…
- Safety Notice for the Compact Oxygen Concentrators (Model 515), deVilbiss Healthcare GmbH
- Urgent field safety notice for sterile Introducer Needle 18G, Kimal plc
- Urgent Field Safety Notice for RIO? SYSTEM IRRIGATION CLIP by MAKO Surgical Corp.
- Corrective action for Human IgM Kit for use on SPA PLUS, Binding Site
- Urgent field safety notice for syngo RT Therapist, Siemens Healthcare GmbH
- Urgent field safety notice for PLATINIUM devices, Sorin Group Deutschland GmbH / LivaNova…
- Corrective action for Bulk Loader Module (BLM), Roche Diagnostics
- Urgent Field Safety Notice for Dilators/Coons Taper, Entuit Secure Adjustable…
- Recall for PSX Proximate® Skin Staple Extractors, ETHICON Endo-Surgery
- Urgent Field Safety Notice for Monnal T50 by Air Liquide Medical Systems
- Urgent Field Safety Notice for AT TORBI 709MP by Carl Zeiss Meditec AG
- Corrective action for the Triathlon Tibial Alignment Ankle Clamp EM (Instrument), Stryker®…
- Corrective action for Nova StatStrip and StatSensor Blood Monitoring Systems, Nova…
- Safety Notice for ultrasound systems APLIO XG and MX, XARIO and XARIO XG, Toshiba
- Urgent Field Safety Notice for Alinity C Processing Module by Abbott GmbH & Co. KG
- Urgent Field Safety Notice for care&serve I premium I Holz-Mundspatel by WIROS Wilfried…
- Urgent Field Safety Notice for VITROS Chemistry Product AMYL Slides Reagent by Ortho…
- Recall of certain lots of the Inzii 12/15mm retrieval system, Applied Medical
About this dataset
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1