- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Units affected
- 2
- Distribution pattern
- US Nationwide distribution in the states of Colorado and Florida.
- Firm location
- Deerfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Telephone
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3257-2026
- Recall initiated
- August 3, 2026
- FDA classification date
- September 23, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99681
- Last updated on HTM Vibe
- October 6, 2026
