FDA Medical Device Recalls (openFDA)
Linet Americas: 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.
- Recall number
- Z-2781-2020
- Recalling firm
- Linet Americas
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2020-03-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- The UDI on the device label indicates incorrect manufacturer.
- Root cause
- Labeling mix-ups
- Action
- AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI
- Quantity
- 202 devices
- Distribution
- 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.
- Lot, serial or model codes
- Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527); Model Number 4BCPPB-CCZ0008, Lot Number PPB1446 - PPB1449; Model Number 4BCPPB-BCZ0009, Lot Number PPB1541 - PPB1542
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HDD
- Firm FEI
- 3008007426
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28