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Class IOngoingUpdated Nov 2, 2026

Baxter Healthcare Corporation recalls 2 products

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Baxter Healthcare Corporation
Reason
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.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the country of Canada.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99119…

Products (2)

  1. Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device

    Codes/lots: UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025Quantity: 16187 unitsRecall no. Z-2550-2026Class I

  2. Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device

    Codes/lots: UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025Quantity: 13881 unitsRecall no. Z-2551-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.
  2. Product details, codes or quantities changed; Units: 10540 units; 0; 16187 units; 13881 units → 16187 units; 13881 units

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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