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CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Read More
Cook Medical is recalling 408,011 of its Beacon Tip Catheter in U.S. markets, due to complaints that the catheter tip may split or separate and could potentially enter the patient’s bloodstream. Read More
Device manufacturer Moss Tubes has been cited for multiple alleged reporting violations tied to product failures, one of which apparently resulted in a patient death. Read More
The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as duodenoscopes. Read More
ECRI Institute is raising safety concerns associated with medical devices ranging from flexible endoscopes to ventilators, calling for an increased awareness of hazards that the products pose to patients. Read More