22 results
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9ms
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Sources: EU EUDAMED, US FDA
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·November 2, 2021
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·July 27, 2023
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·May 5, 2025
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·October 14, 2025
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·April 18, 2023
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDT·December 8, 2023
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q; 6) SNI NEURO, Pack Number DYNJ45379D; 7) VP SHUNT PACK, Pack Number DYNJ55558C
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·February 11, 2025
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Recall
Open, Classified
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 18, 2016
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2025
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·August 25, 2021
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Recall
Open, Classified
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·November 15, 2018
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·December 18, 2024
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
FDA Recall
Open, Classified
·Product code LRO·February 27, 2026