More than 9 million surgical gowns used in many everyday surgical procedures, including open heart surgery and knee replacements, have been recalled because of sterility concerns. Cardinal Health Inc. has placed the blame on a contract manufacturer that made the gowns in "unapproved locations that did not maintain proper environmental conditions."

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.

A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.