State
72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Buprenorphine HCl Injection, 0.3 mg/mL single dose vials, is being recalled because of crystallization identified as buprenorphine free base. 46,334 units are affected.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.
ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.
Medline D and C Packs and a custom cardiovascular pack are being recalled because representative samples did not meet applicable catheter performance specifications. 168 units affected.
ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
Medline procedure kits including robotic cystectomy, D&C and lithotomy packs are being recalled because sample catheters did not meet performance specifications. 32,438 units affected.
Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.
ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.
Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.
Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.
HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.
Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.
Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.
Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.
HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.
BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.
Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.
Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.
Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.
Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.
Med Pride Bacitracin Zinc Ointment, 1 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,185 tubes affected.