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Channel Medsystems, Inc.

FDA Regulatory Profile

Channel Medsystems, Inc. has 2 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Channel Medsystems, Inc." and its spelling variant "Channel Medsystems".

Latest recall
Z-1584-2025 · Class II · Mar 20, 2025
Latest inspection
Feb 1, 2019 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 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

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

Channel Medsystems, Inc.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500010
202400010
202300000
202200000
202100000
202000000
201910000
201810000
201700000

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

2 recall records from May 3, 2024 to Mar 20, 2025.

NumberClassProductDate
Z-1584-2025Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL…Mar 20, 2025
Z-1889-2024Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL…May 3, 2024

Recent FDA inspections

2 inspections from Oct 4, 2018 to Feb 1, 2019.

DateSiteProductClassificationFEI
Feb 1, 2019Berkeley, CADevicesNo Action Indicated (NAI)3012018285
Oct 4, 2018Emeryville, CADevicesVoluntary Action Indicated (VAI)3014711541
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3012018285Berkeley, CA1Feb 1, 2019
FEI 3014711541Emeryville, CA1Oct 4, 2018

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FDA data resources

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