Device recall

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

FDA recall source

Recall number

Z-3257-2026

Event id

99681

Status

Ongoing

FDA classification

Class II

Recalling firm

Baxter Healthcare Corporation

Report date

Sep 30, 2026

Posted

Sep 23, 2026

Initiated

Aug 3, 2026

Center classification date

Sep 23, 2026

Product code

NHJ

Device type

Device, Positive Pressure Breathing, Intermittent

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.

Root cause

Device Design

Quantity

2

Code info

Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853

Distribution

US Nationwide distribution in the states of Colorado and Florida.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K200988

Location

Deerfield, IL, United States