- Recalling firm
- Sarnova HC, Llc
- Reason for recall
- Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
- Affected products (lot / model / serial)
- Lot ASM0043314 UDI-DI 00810094576127
- Units affected
- 2,500 kits
- Distribution pattern
- US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
- Firm location
- Dublin, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0144-2027
- Recall initiated
- June 12, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99838
- Last updated on HTM Vibe
- October 27, 2026
