Facility

TENACORE LLC

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008403701
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	3115 Airway Ave Costa Mesa, CA, US 92626
Registration status	Active · expires 2026
Parent company	Tenacore LLC (owner-operator 10080555)
Brand names	Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

System, Monitoring, Perinatal
Product code HGM (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.2740

Recalls & enforcement

Class ITerminated2021-02-25
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under…

FDA inspections (2)

NAI2026-07-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-08-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Tenacore LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “TENACORE LLC (FEI 3008403701) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008403701-tenacore-llc/

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