Agency classClass IOur severity:Severe FDA (Devices)·Z-2548-2026·Announced 2026-07-08

Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk

Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source indicates this is an FDA Class I recall for a medical device. Per the severity rubric, FDA Class I recalls are scored at minimum 4 (Severe), regardless of whether illnesses have been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085, a positive pressure breathing device used for oscillation lung expansion therapy. The recall affects approximately 10,540 units distributed worldwide, including nationwide in the United States and Canada.

Reports indicate that air and medication can leak from the nebulizer cup during therapy. The leakage occurs due to improper locking of the nebulizer cup after medication is added during user setup. This leakage can lead to a drop in the patient's oxygen level and ineffective nebulization, which may prevent the prescribed treatment from being delivered properly.

Healthcare providers and patients using this device should verify that the nebulizer cup is properly locked after adding medication. For specific instructions on the recall and next steps, contact Baxter Healthcare Corporation. The recall applies to all lot numbers distributed beginning on April 28, 2025 (UDI: 00887761985018).

The recalled product

Product: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Respiratory / Breathing Therapy
Hazard: oxygen-deprivation
medication-leakage
treatment-failure
Affected units: 10,540

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI: 00887761985018
Lot Numbers: All lot numbers distributed beginning on 4/28/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

See all →

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Same hazard · oxygen deprivation