FDA Device recall Z-2781-2020
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search fo…
- FDA Device
- Class III
- ongoing
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class III recall of AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search fo… by Linet Americas, citing the UDI on the device label indicates incorrect manufacturer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2781-2020 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2020-03-06 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Linet Americas |
| Distribution | US |
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.
Reason
The UDI on the device label indicates incorrect manufacturer.
Identifiers
| code_info | Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, P…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2781-2020%22
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