Facility

TECFEN MEDICAL

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3010487482
Establishment type	Repack or Relabel Medical Device
Location	6100 HOLLISTER AVENUE Santa Barbara, CA, US 93117
Registration status	Active · expires 2026
Parent company	TECFEN MEDICAL (owner-operator 10047971)
Brand names	Tecfen Iris Retractor

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Clip, Iris Retractor
Product code HOC (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.4350

Recalls & enforcement

Class IIOngoing2025-04-25
Sterility assurance for Ophthalmic knives.

FDA inspections (2)

NAI2022-03-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-01-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 TECFEN MEDICAL

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. “TECFEN MEDICAL (FEI 3010487482) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010487482-tecfen-medical/

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