FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass I · Medical device · Recalled July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2548-2026
Brand
Baxter Healthcare
Classification
Class I
Units affected
10540 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

Affected products

Companies & origin

Recalling firm location
Deerfield, IL, United States
Firm address
1 Baxter Pkwy, N/A, 60015-4625

Identifying details (verbatim from the notice)

Product codes / lots
UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Firm notified the public via
Letter
FDA event ID
99119
Recall initiated
May 21, 2026
FDA classified
July 1, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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