Facility

Ameda, Inc.

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

Key facts

2recalls · 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)	3009974348
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	8206 Cross Park Dr Austin, TX, US 78754
Registration status	Active · expires 2026
Parent company	Ameda, Inc. (owner-operator 10042362)
Brand names	GLO Wearable Breast Pump

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Pump, Breast, Powered
Product code HGX (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.5160

Recalls & enforcement

Class IIIOngoing2017-07-10
Two specific lots was incorrectly manufactured containing a UK power adapter.
Class IITerminated2015-02-12
Devices were not sterilized

FDA inspections (1)

NAI2017-09-21
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 Ameda, 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. “Ameda, Inc. (FEI 3009974348) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009974348-ameda-inc/

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