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Sources: EU EUDAMED, US FDA
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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 30, 2024
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 19, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGR·August 4, 2025
Access Immunoassay Systems CORTISOL, Part Number: 33600
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGR·February 17, 2010
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGR·September 18, 2018
Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGR·July 20, 2009
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code CGR·September 19, 2014
Invacare 2G Tarsys Seating System, Model 2GR.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·December 15, 2003
BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code FAD·October 13, 2016
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code FAD·October 13, 2016
Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code FPA·April 2, 2009
Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005
C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code FAS·October 12, 2016
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
FDA Recall
Terminated
·Bard Access Systems·Product code KMK·June 10, 2013
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JDI·May 7, 2021
Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code FAD·October 13, 2016
Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent; Bard Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code FAD·October 13, 2016
Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code KNT·October 28, 2010
Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
FDA Recall
Terminated
·Ram Medical Inc·Product code FTL·March 5, 2010
Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
FDA Recall
Terminated
·Ram Medical Inc·Product code FTL·March 5, 2010