State
72,940 recalls have nationwide distribution and so reach South Dakota. 2,681 additional recalls listed South Dakota specifically in their distribution scope.
Of the 2,681 recalls naming South Dakota we have scored against our rubric, 401 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 565 (21%) are Severe.
Which agencies issued them
These figures cover only the 2,681 recalls whose distribution notice names South Dakota specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.
Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.
Graviti Pharmaceuticals is recalling 4,212 bottles of Furosemide Tablets, USP 40 mg over the presence of a foreign substance.
GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.
Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.
Mazor Robotics is recalling 549 Mazor X robotic guidance systems over software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.
Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.
Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.
ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.
Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.
ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Catao Market is recalling 260 master cases (3,120 loaf cakes) of Mini Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.
Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.
Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 3,824 units of its Patient Monitor models X8, X10 and X12 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System after an FDA letter raising potential cybersecurity issues with the firm's devices.
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.
Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.
Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.
Edan Diagnostics is recalling 12,201 units of its M3A Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.