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Hillrom Volara System Patient Circuit Kit
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MEDICAL DEVICE RECALLCRITICAL

Hillrom Volara System Patient Circuit Kit

Baxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing oxygen drop and ineffective treatment.

What to do

Stop using the affected Volara system patient circuit kit and contact Baxter Healthcare for instructions on returning the product and obtaining a replacement. Ensure the nebulizer cup is properly locked after adding medication to prevent leakage.

Recalled
Listed
Updated
Recall No.
Z-2550-2026
Agency
FDA
Firm
Baxter Healthcare Corporation
Recall ID
99119
Status
ONGOING

Why it was recalled

Baxter Healthcare is recalling the Hillrom Volara System P.CIRCUIT KIT (Single Patient Use Circuit), REF M08085, an oscillation lung expansion therapy device. Air and medication leakage from the nebulizer cup during therapy can cause an oxygen level drop in the patient and ineffective nebulization, potentially affecting delivery of prescribed treatment. The issue is associated with improper locking of the nebulizer cup after adding medication during user setup.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Lot code: 2025

ProductRecall #UDI-DI
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing deviceZ-2550-202600887761981492
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing deviceZ-2551-202610887761981499
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing deviceZ-2549-202610887761985015
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing deviceZ-2548-202600887761985018

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification