Facility

DRAEGER, INC.

6 recall(s) on record — most severe on record: Class I.

Key facts

6recalls · worst Class I

—inspections in our data

—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)	3009348423
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	7256 S. Sam Houston W. Parkway Houston, TX, US 77085
Registration status	Active · expires 2026
Parent company	Draeger, Inc. (owner-operator 10052404)
Brand names	Draeger Alcotest 3820; Draeger Alcotest 5820; Draeger Alcotest 5000

Activity by year

Recalls (6)

Devices registered here (1)

Devices, Breath Trapping, Alcohol
Product code DJZ (opens in a new tab) · Class I · Clinical Toxicology · 21 CFR 862.3050

Recalls & enforcement

Class IOngoing2026-05-07
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class IOngoing2025-11-24
A certain component of affected devices was not delivered within specification and contained impurities.
Class IOngoing2025-11-10
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class IOngoing2025-09-09
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class IOngoing2025-06-16
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Class IOngoing2025-03-12
The potential for cracks forming in the breathing circuit hose.

All facilities operated by Draeger, 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. “DRAEGER, INC. (FEI 3009348423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009348423-draeger-inc/

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