Babi.Plus BC23-HDRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K110383); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 30, 2019Terminated

   Reports of pressure relief manifold venting gas below the standard pressure.

   Z-0022-2020 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110383. One submission often covers many models, so check the product and lot details in each record.

• Z-0009-2020 · Jun 14, 2019 · Terminated
  Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
• Z-0021-2020 · May 30, 2019 · Terminated
  Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
• Z-0020-2020 · May 30, 2019 · Terminated
  Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562