Samsung Electronics has formally recalled 1 million Galaxy Note 7 smartphones sold in the US, replacing or refunding the flagship phones.
The phone's susceptibility to catching fire has damaged the image of the Korean company.
Samsung received 92 reports of batteries overheating in the US, including 26 reports of burns and 55 cases of property damage, the company said as it announced the recall in cooperation with the US Consumer Product Safety Commission.
The recall is a costly setback for Samsung, which was counting on Galaxy Note 7 to bolster sales as rivals such as Apple launch new devices.
The scale of the recall is unprecedented for Samsung, the world's largest smartphone maker.
Samsung said that new Note 7 replacement devices will be available at most retail locations in the US no later than September 21.
Earlier this month, Samsung said it would recall all Note 7 smartphones equipped with batteries it found to be fire-prone and halted their sales in 10 markets, denting a revival of the firm's mobile business.
While recalls in the smartphone industry do happen, including for rival Apple, the nature of the problem for the Note 7 is a serious blow to Samsung's reputation, analysts have said.
Some 2.5 million of the premium devices worldwide need to be recalled, Samsung said. Some analysts say the recall could cost Samsung nearly $5 billion in lost revenue this year.