State
73,219 recalls have nationwide distribution and so reach North Dakota. 2,924 additional recalls listed North Dakota specifically in their distribution scope.
Of the 2,924 recalls naming North Dakota we have scored against our rubric, 265 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 729 (25%) are Severe.
Which agencies issued them
These figures cover only the 2,924 recalls whose distribution notice names North Dakota specifically. The 73,219 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a specific feedthrough defect. The 4,767 affected units were distributed nationwide and worldwide.
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.
Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.
Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.
Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.
Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.
Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.
Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.
Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.
Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.
ST Engineering Hackney is recalling 2011-2021 Kidron refrigerated truck bodies because a centrifugal clutch may overheat and break, creating a fire hazard.
Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.
Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.