The FDA announced Monday that an investigation has been launched into problems with certain types of medical device power cords, including those used with devices manufactured by Hospira, Inc. and…
The FDA has ordered the manufacturers of new, flexible pedicle screw spinal fusion implants, known as dynamic stabilization systems, to conduct more research on potential problems with the devices, including…
The FDA is admitting that pressure from lawmakers played a factor in the approval of the Menaflex knee replacement device by ReGen Biologics Inc., which may have unleashed an unsafe…
The FDA is requiring manufacturers of the anti-nausea drug promethazine, which is a generic version of Phenergan, to include a “black box” warning on the drug’s labels about the risk…
The FDA has sent baby product maker Evenflo a warning letter for failing to investigate reports that some women received electric shocks while using its “Comfort Select” breast pumps.
The ConMed Linvatec Power Pro, a universal hand tool for orthopedic surgical attachments, has been recalled because it can randomly cause surgical tools to act erratically, potentially causing severe patient…
A design defect that could result in the death of hospitalized infants has led the FDA to notify healthcare providers about a Class I recall for Covidien Pedi-Cap End-Tidal CO2…
A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court…
A new study seems to indicate that the bone growth agent in the Medtronic Infuse bone graft may be linked to life-threatening problems after neck surgery, where it may cause…
A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices.…