CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled
Sarnova HC is recalling Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack, distributed nationwide in the US. The recall was initiated on 12 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0144-2027
- FDA event ID
- 99838
- Recalling firm
- Sarnova HC, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jun 2026
- FDA classified
- 9 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 12 Jun 2026 | Recall initiated by company | |
| 9 Oct 2026 | Classified by FDA | +119 days |
| 21 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Product as listed by the FDA
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Where it was distributed
US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
Nationwide IowaIllinoisIndianaKentuckyMichiganMinnesotaMissouriNorth DakotaOhioUtah
Questions about this recall
Why was it recalled?
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Which lots are affected?
Lot ASM0043314 UDI-DI 00810094576127
Where was it sold?
US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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