The U.S. Food and Drug Administration (FDA) remains unsatisfied with the status of a product recall by healthcare technology company Philips , the regulator said in an update.
Philips has recalled millions of sleep apnea and respiratory devices since 2021.
In the update published overnight, the FDA said it believed Amsterdam-headquartered Philips should conduct additional testing on the risk posed to people who used recalled devices.
Philips could not immediately be reached for comment.
"This is negative news," analysts from Bernstein said in a note. "The FDA is clearly still not happy with the way the recall is being handled."
The long-running recall wiped out more than two-thirds of Philips' market valuation in 2021-2022, but it has staged a modest recovery in 2023.
Shares were down 6.6% at 17.32 euros at 0703 GMT on Friday.