55 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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Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code KLB·April 5, 2007
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code KLB·April 5, 2007
VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·August 6, 2004
Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·August 6, 2004
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Recall
Open, Classified
·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025
HoverMatt Patient Transfer Solution/Air Transfer Mattress
FDA Recall
Terminated
·D.T. Davis Enterprises Ltd.·Product code FRZ·September 13, 2005
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010
VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·April 26, 2012
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DJG·September 4, 2019
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Recall
Terminated
·B Braun Medical, Inc.·Product code FRN·October 31, 2012
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025