Z-2781-2020Class III

AVE 2 Birthing Bed -

Name: Z-2781-2020 AVE 2 Birthing Bed -
Creator: Linet Americas
Published: 2020-03-06
License: https://open.fda.gov/license/

Linet Americas / initiated 2020-03-06 / Open, Classified / root cause: labeling and UDI

FDA source

Linet Americas began a 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 for individual... on 2020-03-06. FDA classified it as Class III and gives the reason as "The UDI on the device label indicates incorrect manufacturer". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2781-2020
Classification: Class III
Status: Open, Classified
Initiated: 2020-03-06
Posted: 2020-08-12
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.
Product code: HDD Table, Obstetrical, Ac-Powered (And Accessories)
Reason for recall: The UDI on the device label indicates incorrect manufacturer.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2781-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2781-2020	Class III	Ongoing	Voluntary: Firm initiated	2020-08-19	2020-08-12

Product code HDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)