C.R. Bard Recalls Ureteral Stent Kit Due to Labeling Discrepancy
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.
Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.
Safety and efficacy of dialysis acid concentrate cannot be assured
Product testing did not meet expected stability criteria.
Defective container - seal not adhering to bottles
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.