Bunnell 903Recalls & 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, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (P850064); 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. Nov 2, 2022Open, Classified

   Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.

   Z-0371-2023 · Root cause: Packaging process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P850064. One submission often covers many models, so check the product and lot details in each record.

• Z-0514-2013 · Nov 19, 2012 · Terminated
  Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s):
• Z-0901-2011 · Oct 25, 2010 · Terminated
  One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
• Z-0902-2011 · Oct 25, 2010 · Terminated
  One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
• Z-0893-06 · Apr 4, 2005 · Terminated
  Life Pulse High Frequency Ventilator (HFV)