SUMMARY OF FIELD SAFETY NOTIFICATIONS / APRIL 2026
USER INFORMATION
Rezultate posibil fals rezistente la antibiotice la cardurile VITEK® 2 AST GN pentru speciile Enterobacterales și/sau Pseudomonas aeruginosa / manufacturer bioMérieux, Inc., SUA
Ref. ANMDMR: 127/26
USER INFORMATION
Lampă chirurgicală Merivaara Qflow/ manufacturer Merivaara Corporation, Finlanda
Ref. ANMDMR: 216/26
PRODUCT RECALL
Eyevisc™ / manufacturer Biotech Visioncare Pvt. Ltd., India
Ref. ANMDMR: 677/26
USER INFORMATION
Cateter Swan Ganz / manufacturer Edwards Lifesciences LLC, SUA
Ref. ANMDMR: 679/26
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Test Thermo Fisher Scientific BRAHMS PlGF Plus KRYPTOR / manufacturer B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific, Germania
Ref. ANMDMR: 724/26
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Forceps și foarfece DEX / manufacturer Katalyst Surgical LLC, SUA
Ref. ANMDMR: 730/26
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NEXUS MEDIKATION/ manufacturer NEXUS / CMC GmbH, Germania
Ref. ANMDMR: 733/26
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Tuburi intrauterine / manufacturer Nucletron B.V., Tarile de Jos
Ref. ANMDMR: 734/26
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Neonatal heat therapy devices / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 736/26
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Vue Motion V12 / manufacturer Philips Medical Systems Nederland B.V., Ţările de Jos
Ref. ANMDMR: 740/26
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HF Cable, Bipolar / manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 758/26
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ipsogen kit/ manufacturer QIAGEN GmbH, Germania
Ref. ANMDMR: 759/26
PRODUCT RECALL
Catetere cu balon de crioablație POLARx™ și POLARx™ Fit, teci ghidabile POLARSHEATH™ / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 765/26
PRODUCT RECALL
Sisteme de stenturiE-vita OPEN NEO , E-tegra ,E-nside TAAA Multibranch / manufacturer JOTEC GmbH, Germania
Ref. ANMDMR: 768/26
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STHEMO ANTI Xa M / manufacturer Diagnostica Stago, Franta
Ref. ANMDMR: 770/26
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Modul Flex Infusion (Perfuzie flexibilă) al SynchroMed™ / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 772/26
USER INFORMATION
Ruperea șuruburilor suportului de canulă de la sistemele da Vinci X, Xi / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 774/26
PRODUCT RECALL
Suruburi AR-8933L-16 / manufacturer Arthrex INC, SUA
Ref. ANMDMR: 780/26
USER INFORMATION
Non-Tamperproof Battery Door / manufacturer Advanced Bionics LLC, SUA
Ref. ANMDMR: 783/26
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Seringă de control angiografic Namic cu adaptor rotativ (RA) (seringi Namic RA) / manufacturer Medline Industries, LP, SUA
Ref. ANMDMR: 786/26
PRODUCT RECALL
Dispozitiv chirurgical Thunderbeat™ II / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 797/26
PRODUCT RECALL
Merit 16F Dual-Valved Splittable Sheath Introducer / manufacturer Arrow International LLC (Subsidiary of Teleflex Incorporated), SUA
Ref. ANMDMR: 799/26
USER INFORMATION
Edwards EVOQUE Tricuspid Valve Replacement System / manufacturer Edwards Lifesciences LLC, SUA
Ref. ANMDMR: 813/26
USER INFORMATION
Avantgarde 4 and Zenit / manufacturer Otto Bock Mobility Solutions GmbH, Germania
Ref. ANMDMR: 839/26
USER INFORMATION
Gamma-GT Reagent / manufacturer VitalScientific, SUA
Ref. ANMDMR: 842/26
PRODUCT RECALL
InZone Detachment System/ manufacturer Stryker Neurovascular, SUA
Ref. ANMDMR: 846/26
PRODUCT RECALL
Sperm Concentration Rapid Test Kit and Bowel Health Rapid Test Kit/ manufacturer Hangzhou Alltest Biotech Co.,Ltd., China
Ref. ANMDMR: 850/26
USER INFORMATION
Orbis Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 851/26
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Sistemele Philips Azurion / manufacturer Philips Medical Systems Nederland B.V., Tarile de Jos
Ref. ANMDMR: 852/26
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Cryo.s with External Thread / manufacturer Greiner Bio-One GmbH, Germania
Ref. ANMDMR: 863/26
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Sistem de analiză a sângelui Epoc® / manufacturer Epocal Inc., Canada
Ref. ANMDMR: 866/26
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AmpliCube Respiratory Viral Panel 5 with ampliCube Respiratory Viral Panel 1 / manufacturer Mikrogen GmbH, Germania
Ref. ANMDMR: 870/26
USER INFORMATION
Navify® Digital Pathology / manufacturer Ventana Medical Systems Inc., Germania
Ref. ANMDMR: 881/26
PRODUCT RECALL
Aural Vent Tubes (PTFE) / manufacturer Exmoor Plastics Limited, Marea Britanie
Ref. ANMDMR: 885/26
USER INFORMATION
CO2 Laser Systems and VersaPulse PowerSuite (VPPS) Dual Wavelength (DW) / manufacturer Lumenis Ltd, Israel
Ref. ANMDMR: 886/26
PRODUCT RECALL
Huber Needles Polyperf / manufacturer Perouse Medical, Franta
Ref. ANMDMR: 887/26
USER INFORMATION
Vivo 45 LS / manufacturer Breas Medical AB, Suedia
Ref. ANMDMR: 890/26
USER INFORMATION
TRAb human 1 step RIA / manufacturer Medipan GmbH, Germania
Ref. ANMDMR: 893/26
PRODUCT RECALL
ELEC®plus Ceramic Femoral Head andELEC®plus Revision Ceramic Femoral Head / manufacturer Artiqo GmbH, Germania
Ref. ANMDMR: 905/26
PRODUCT RECALL
Medistrip- Vein Stripper / manufacturer Neuromedex GmbH, Germania
Ref. ANMDMR: 908/26
PRODUCT RECALL
Bobby™ Balloon Guide Catheter / manufacturer MicroVention, Inc., SUA
Ref. ANMDMR: 910/26
USER INFORMATION
Palamix® uno și Palamix® duo / manufacturer Heraeus Medical GmbH, Germania
Ref. ANMDMR: 917/26
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Seringă de control pentru angiografie cu adaptor rotativ (RA) în pachet procedural Kimal / manufacturer Kimal PLC, Marea Britanie
Ref. ANMDMR: 919/26
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Amplificator EEG / manufacturer Micromed S.p.A, Italia
Ref. ANMDMR: 927/26
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Impella Purge Cassette / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 934/26
USER INFORMATION
Dexcom G7 / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 935/26
USER INFORMATION
Single Use Ligating Device / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1626/25
USER INFORMATION
HemosIL SynthAsyl/ manufacturer Instrumentation Laboratory Co., SUA
Ref. ANMDMR: 3324/26
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GEM PAKs/ manufacturer Instrumentation Laboratory Co., SUA
Ref. ANMDMR: 17986/26
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Calibratori de Heparină HemosIL/ manufacturer Instrumentation Laboratory Co., SUA
Ref. ANMDMR: 24170/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.