Facility

RMO

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

Key facts

7recalls · 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)	3030970580
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	19, Jalan Firma 1/5, Kawasan Perindustrian Tebrau 1 Johor Bahru, MY 81100
Registration status	Active · expires 2026
Parent company	RESMED CORP. (owner-operator 9002319)

Activity by year

Recalls (7)

Devices registered here (1)

Ventilator, Non-Continuous (Respirator)
Product code BZD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905

Recalls & enforcement

Class IOngoing2026-06-25
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Class IOngoing2023-11-20
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about …
Class IOngoing2023-09-13
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered…
Class ICompleted2019-12-12
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of…
Class IITerminated2016-07-12
Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
Class IITerminated2016-01-13
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Class IITerminated2015-05-05
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result i…

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. “RMO (FEI 3030970580) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030970580-rmo/

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RMO