AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Recall Z-2781-2020 · Posted None
Recalling FirmLinet Americas
Recall StatusOpen, Classified
Product CodeHDD
Date Initiated2020-03-06
Product Quantity202 devices
Reason for Recall
The UDI on the device label indicates incorrect manufacturer.
Firm Action
AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide distribution including in the states of Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia and Puerto Rico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.