The FBI is probing what Johnson & Johnson knew about the risks of a surgical tool found to spread uterine cancer before withdrawing its version of the laparoscopic power morcellator last year.
J&J said in July that it would ask doctors to return the device which is used to treat uterine growths called fibroids, reported Reuters.
It is unclear what stage the inquiry is in. The Wall Street Journal cited three people who have been interviewed.
A J&J spokesman said the company has not been contacted by the FBI regarding its Ethicon morcellation devices.
The U.S. Food and Drug Administration tightened its guidelines on the use of a uterine surgical technique in November, saying it has been linked to the spread of a rare type of cancer.
This came after the agency issued an alert in April last year discouraging the use of the devices to remove fibroids.
The devices are used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening. The procedure is designed to shorten recovery time and reduce wound-site infections.
Yet the technique can cause injury to local tissues and organs and spread unsuspected malignant tissue to places outside the uterus.