Fresenius Medical Care North America
FDA adverse event reports naming Fresenius Medical Care North America as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: FRESENIUS MEDICAL CARE NORTH AMERICA.
- Total reports
- 37,655
- Deaths
- 24,684
- Injuries
- 8,790
- Malfunctions
- 4,032
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)KPO28,014
- System, Peritoneal, Automatic DeliveryFKX3,513
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI3,324
- Dialyzer, Capillary, Hollow FiberFJI1,668
- Accessories, Blood Circuit, HemodialysisKOC613
- Set, Tubing, Blood, With And Without Anti-Regurgitation ValveFJK243
- System, Dialysate Delivery, SealedFII109
- Hemodialysis System For Home UseONW80
- Set, Administration, For Peritoneal Dialysis, DisposableKDJ41
- System, Dialysate Delivery, Semi-Automatic, PeritonealKPF21
Recent recalls
- 2010-08-15TerminatedComponent design/selection
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-08-15TerminatedComponent design/selection
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-08-15TerminatedComponent design/selection
Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-08-15TerminatedComponent design/selection
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-07-01TerminatedProcess control
Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.
Hemodialyzer may leak at the header/end cap
- 2009-01-23TerminatedProcess control
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- 2009-01-23TerminatedProcess control
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- 2008-02-01TerminatedProcess control
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
- 2006-05-03TerminatedOther
Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
Stay safe trigger body may not connect to the extension set and result in associated peritonitis
- 2005-12-31TerminatedOther
Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
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