Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.

Philips, which has been struggling with a major recall of ventilators, on Monday flagged further problems with some machines it has previously replaced, according to an FDA statement.

The agency said it received more than 48,000 reports of faulty Dutch medical equipment maker Philips’ ventilators and respiratory devices between May and July of this year.