Facility

REVMEDX, INC.

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

Key facts

1recalls · worst Class II

1inspections · 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)	3009035955
Establishment type	Manufacture Medical Device
Location	25749 SW CANYON CREEK RD STE 300 Wilsonville, OR, US 97070
Registration status	Active · expires 2026
Parent company	RevMedx, Inc. (owner-operator 10045345)
Brand names	XSTAT 30 Generation 2; XSTAT 30; XSTAT 30 Gen2

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Gauze / Sponge,Nonresorbable For External Use
Product code NAB (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4014
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Product code PGZ (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4452

Recalls & enforcement

Class IITerminated2015-08-12
The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the de…

FDA inspections (1)

NAI2019-09-26
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 RevMedx, 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. “REVMEDX, INC. (FEI 3009035955) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009035955-revmedx-inc/

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