CLASS III ONGOING Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
AVE 2 Birthing Bed recalled by Linet Americas
Linet Americas is recalling AVE 2 Birthing Bed, distributed nationwide in the US. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2781-2020
- FDA event ID
- 85094
- Recalling firm
- Linet Americas, Charlotte, NC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 6 Mar 2020
- FDA classified
- 12 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 6 Mar 2020 | Recall initiated by company | |
| 12 Aug 2020 | Classified by FDA | +159 days |
| 19 Aug 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The UDI on the device label indicates incorrect manufacturer.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasCaliforniaDelawareFloridaGeorgiaIndianaLouisianaMassachusettsMinnesotaMissouriMississippiNew JerseyOklahomaPennsylvaniaPuerto RicoTennesseeTexasVirginiaWest Virginia
Questions about this recall
Is AVE 2 Birthing Bed recalled?
Yes. Linet Americas recalled AVE 2 Birthing Bed on 6 Mar 2020. The recall is Class III and its status is Ongoing. Recall number Z-2781-2020.
Why was it recalled?
The UDI on the device label indicates incorrect manufacturer.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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