Facility

KENTEC MEDICAL, LLC

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · 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)	2080225
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	17871 FITCH Irvine, CA, US 92614
Registration status	Active · expires 2026
Parent company	KENTEC MEDICAL, INC. (owner-operator 2080225)
Brand names	Ameritus ENFit enteral feeding tube(vr)

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Gastrointestinal Tubes With Enteral Specific Connectors
Product code PIF (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980
Tubes, Gastrointestinal (And Accessories)
Product code KNT (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980
Tube, Feeding
Product code FPD (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980

Recalls & enforcement

Class IITerminated2020-01-17
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiat…
Class IITerminated2017-06-23
Inadequate detectability of radiopaque stripes

FDA inspections (1)

VAI2018-07-30
Voluntary 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 KENTEC MEDICAL, INC.

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. “KENTEC MEDICAL, LLC (FEI 2080225) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2080225-kentec-medical-llc/

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