69 results
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26ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·October 25, 2024
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FEQ·September 11, 2015
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·June 4, 2013
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-25-E-MNP. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile, Catalog Number: C-PLI-7.0-35-X-1. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·December 7, 2007
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code EOQ·May 26, 2023
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·May 26, 2023
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·May 26, 2023
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code EOQ·May 26, 2023
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·May 26, 2023
Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code JDH·December 9, 2004
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
FDA Recall
Terminated
·Fisher Diagnostics·Product code KQJ·May 19, 2017
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
FDA Recall
Terminated
·Fisher Diagnostics·Product code KQJ·May 19, 2017