Facility

BC GROUP INTERNATIONAL, INC.

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

Key facts

1recalls · worst Class III

2inspections · 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)	2939012
Establishment type	Manufacture Medical Device
Location	3081 Elm Point Industrial Dr Saint Charles, MO, US 63301
Registration status	Active · expires 2026
Parent company	BC Group International, Inc. (owner-operator 10037117)
Brand names	DA-2006P; DA-2006

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Tester, Defibrillator
Product code DRL (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5325

Recalls & enforcement

Class IIITerminated2015-10-28
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

FDA inspections (2)

VAI2024-04-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-09-12
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 BC Group International, 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. “BC GROUP INTERNATIONAL, INC. (FEI 2939012) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2939012-bc-group-international-inc/

Not open yet

Alerts for BC GROUP INTERNATIONAL, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.