The U.S. Food and Drug Administration (FDA) on Wednesday issued an early alert highlighting a potentially high-risk issue with stapling devices manufactured by Intuitive Surgical, Inc. (NASDAQ:ISRG).

Affected Stapler Devices Pulled From Use

The FDA said Intuitive Surgical notified customers to remove specific curved-tip staplers from use or distribution.

The affected products include the 8mm SureForm 30 Gray Reload, tied to designated parts and identification numbers.

Customers have been directed to identify and stop using the impacted devices immediately.

The company has also advised quarantining the products and ensuring any distributed units are located and returned.

Device Widely Used Across Surgical Specialties

The affected stapling system is ...