The FDA has posted 5 enforcement recalls of intermittent positive pressure breathing device devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potentia…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Device, Positive Pressure Breathing, Intermittent”). Informational only — verify against the FDA before acting.