Brand Name: VOLARA System Product Name: VOLARA recall (Baxter Healthcare Corporation)

Medical deviceClass IIOngoing

Summary: Baxter Healthcare Corporation is recalling 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. 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of Colorado and Florida. (states named: Colorado, Florida)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Baxter Healthcare Corporation · all medical device recalls · recalls from August 2026

Official FDA record