Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
What this means
The nebulizer cup on Hillrom Volara P.Circuit 5Kit devices can leak air and medication if not properly locked during setup. This leakage may reduce oxygen delivery to the patient and prevent the prescribed medication from being delivered effectively.
- Check that the nebulizer cup is fully and securely locked after adding medication
- Contact Hillrom or your equipment supplier if you have questions about proper setup
- Report any leakage or delivery problems to your healthcare provider immediately
The agency's original wording
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2026More Baxter recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.