Hill-Rom Manufacturing, Inc. FLEXICAIR MC3 Low Airloss Therapy unit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FLEXICAIR MC3 Low Airloss Therapy unit
Brand
Hill-Rom Manufacturing, Inc.
Lot Codes / Batch Numbers
MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).
Products Sold
MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).
Hill-Rom Manufacturing, Inc. is recalling FLEXICAIR MC3 Low Airloss Therapy unit due to Reports of patient entrapment between mattress and side-rails.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of patient entrapment between mattress and side-rails.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026