Intuitive Surgical (NSDQ:ISRG) is dealing with a global recall of hundreds of thousands of disposable drapes used with its da Vinci robot-assisted surgery system made by Microtek Medical.
Intuitive issued a field safety notice to customers March 16, alerting them to a "cloudy/waxy" issue with some 440,000 Microtek drapes used with its da Vinci SI disposable accessory kit 3 ARM (5 pack).
The FDA this week gave the recall Class II status because of the safety risks involved.
The recall covers drapes distributed worldwide to countries including Austria, Australia, Belgium, China, Cyprus, Egypt, Finland, Monaco, Pakistan, Venezuela, Vietnam, Switzerland, Qatar, Romania, Russia and Saudi Arabia.
In March, Sunnyvale, Calif.-based Intuitive won a 5-year contract worth as much as $430 million for the da Vinci device, a deal that covers instruments, accessories and upgrades.