Facility

SUNSTAR AMERICAS, INC.

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

Key facts

4recalls · worst Class II

2inspections · worst OAI

—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)	1413787
Establishment type	Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	301 East Central Road Schaumburg, IL, US 60195
Registration status	Active · expires 2026
Parent company	Sunstar Americas, Inc. (owner-operator 9016423)
Brand names	GUM® Proxabrush Interdental Brush 1.2mm; GUM® Proxabrush Interdental Brush 1.3mm; GUM® Proxabrush Interdental Brush 1.4mm; GUM® Proxabrush Interdental Brush 1.1mm; TRAV-LER; GUM® Proxabrush Interdental Brush 1.6mm; GUM® Proxabrush Interdental Brush 0.8mm; GUM® Proxabrush Interdental Brush 0.6mm

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Toothbrush, Manual
Product code EFW (opens in a new tab) · Class I · Dental · 21 CFR 872.6855

Recalls & enforcement

Class IITerminated2022-01-14
Product lacks premarket clearance.
Class IITerminated2021-05-21
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Class IITerminated2021-03-23
Product may be contaminated with Burkholderia contaminans.
Class IITerminated2021-02-18
The product may be contaminated with Burkholderia cepacia

FDA inspections (2)

VAI2023-02-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2021-02-18
Official 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 Sunstar Americas, 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. “SUNSTAR AMERICAS, INC. (FEI 1413787) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1413787-sunstar-americas-inc/

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