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Sources: EU EUDAMED, US FDA
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HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code LGZ·October 31, 2016
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Recall
Terminated
·Focus Diagnostics Inc·Product code LHL·February 15, 2017
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
FDA Recall
Terminated
·Diamedix Corporation·Product code LHL·December 23, 2004
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Recall
Terminated
·Focus Diagnostics Inc·Product code LHL·February 15, 2017
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA Recall
Terminated
·bioMerieux·Product code LJC·August 6, 2003
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
FDA Recall
Open, Classified
·Northgate Technologies, Inc.·Product code FFK·October 25, 2021
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code FFK·May 24, 2017
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OIB·March 9, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OVN·March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OWL·December 22, 2025
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code LRS·March 9, 2026
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code MID·June 22, 2001
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code DHR·November 9, 2001
Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
FDA Recall
Terminated
·Zeus Scientific Inc·Product code LFX·February 24, 2000