Sarnova HC, Llc

FDA Regulatory Profile

Sarnova HC, Llc has 5 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Sarnova HC, Llc" and its spelling variant "Sarnova Hc".

Latest recall
Z-0144-2027 · Class II · Jun 12, 2026
Latest inspection
Aug 26, 2015 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls5Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Sarnova HC, Llc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Sarnova HC, Llc: FDA recall records per year 2017: 0 recall records020172018: 0 recall records020182019: 0 recall records020192020: 0 recall records020202021: 0 recall records020212022: 0 recall records020222023: 2 recall records220232024: 2 recall records220242025: 0 recall records020252026: 1 recall records12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600010
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Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

5 recall records from Nov 6, 2023 to Jun 12, 2026.

NumberClassProductDate
Z-0144-2027Class IICuraplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KITJun 12, 2026
Z-1308-2024Class IICuraplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an…Feb 12, 2024
Z-1307-2024Class IICuraplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an…Feb 12, 2024
Z-0721-2024Class IICuraplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The…Nov 6, 2023
Z-0720-2024Class IICuraplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals…Nov 6, 2023

Recent FDA inspections

2 inspections from Feb 22, 2012 to Aug 26, 2015.

DateSiteProductClassificationFEI
Aug 26, 2015Dublin, OHDevicesVoluntary Action Indicated (VAI)3014680755
Feb 22, 2012Dublin, OHDevicesVoluntary Action Indicated (VAI)3014680755
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014680755Dublin, OH2Aug 26, 2015

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.