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Cook Medical announced a global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides due to the possibility of glass particles in the coating of the wire guide units. Read More
The FDA is once again warning healthcare facilities to stop using an endoscope reprocessor system from Custom Ultrasonics to disinfect duodenoscopes. Read More
The FDA has asked manufacturers of syringe pumps to update their labels to address flow continuity concerns that the agency identified as a serious risk to health. Read More
Alere said it will remove its INRatio and INRatio2 PT/INR monitoring system from the market and discontinue manufacturing the product line following a Class I recall due to inaccurate test results. Read More
The FDA handed a warning letter to Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, for failing to properly manage its suppliers and handle complaints. Read More
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More
Poor supplier controls remain one of the top five FDA citations for device manufacturers, and with outsourcing continuing to grow, supplier networks can become a complicated web to manage. Read More