OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA

Recall date · record updated Sep 30, 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
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of Colorado and Florida.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99681…

Products

  1. Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No

    Codes/lots: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853Quantity: 2Recall no. Z-3257-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

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

More Medicines & devices recalls