August 15, 2022

The FDA updated its safety communication related to the recall with new information on MDRs. From May 1, 2022 through July 31, 2022 the FDA received more than 48,000 MDRs, more than twice as many as the last period, including 44 reports of deaths associated with PE-PUR foam breakdown or suspected foam breakdown. The FDA is continuing an in-depth review and analysis, including examining the possible reasons for the increased number of reports during this time.