Samsung has urged owners of the Galaxy Note 7 to turn off the smartphone while it investigates new reports of the device catching fire.
The South Korean firm also said it would stop all sales of the phone.
Samsung recalled 2.5 million phones in September after complaints of exploding batteries and later assured customers that all replaced devices were safe.
But there are now reports that even those phones that had been replaced were catching fire.
A man in Kentucky said he woke up to a bedroom full of smoke from a replaced Note 7, days after a domestic flight in the US was evacuated after a new device started emitting smoke in the cabin.
"Because consumers' safety remains our top priority, Samsung will ask all carrier and retail partners globally to stop sales and exchanges of the Galaxy Note 7 while the investigation is taking place," the company said.
"Consumers with either an original Galaxy Note 7 or replacement Galaxy Note 7 device should power down and stop using the device and take advantage of the remedies available," it added.
South Korean media reports suggest the company is likely to stop selling the phone permanently.
The problems for Samsung come at a crucial time for the firm, technology analyst Andrew Milroy of Frost & Sullivan told the BBC.
"Samsung had been making a comeback against its rivals. This catastrophic product fault will seriously damage its competitive position in the smart phone market," he said.
Jake Saunders of ABI research said the situation for Samsung was now "very serious" with "the consequences beginning to snowball".
"The concern now will be the knock-on consequences on the reputation of the brand."
The US consumer protection agency has also urged people not to use their Samsung replacement devices.
"No one should have to be concerned their phone will endanger them, their family or their property," Elliot Kaye, chairman of the safety commission, said. He called Samsung's decision to stop distributing the device "the right move" in light of "ongoing safety concerns".
The South Korean transport ministry on Tuesday said people should not use or charge their Note 7 devices on a plane.
The original Note 7 had already been banned by numerous aviation authorities and airlines around the world.
On Monday, US mobile networks AT&T and T-Mobile had already stopped replacing or selling the phone. In the UK, Vodafone and EE had suspended replacements.