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RESMED PTY LTD. FDA Inspection Record

FEI 3004604967 · Inspections, Form 483s, warning letters and import refusals

RESMED PTY LTD. is an FDA-registered facility (FEI 3004604967) located in BELLA VISTA New South Wales, AU. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 13, 2014: No Action Indicated (NAI)
Inspections on record
2 (2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
5, latest Jun 25, 2026
Import refusals
3

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 13, 2014No Action Indicated (NAI)No citations listed
Feb 3, 2011No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jun 25, 2026Class IZ-2735-2026Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state…
Nov 20, 2023Class IZ-0536-2024AirFit N10 Nasal Masks and User Guide and 6 more products
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical…
Sep 13, 2023Class IZ-0111-2024Astral 100 and Astral 150 ventilators
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a…
Dec 12, 2019Class IZ-0915-2020ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators…
May 5, 2015Class IIZ-1750-2015Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of…

FDA record score

37 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Class I recall Z-2735-2026, this FEI as the recalling firmJun 25, 202615 x 115
Class I recall Z-0536-2024, this FEI as the recalling firmNov 20, 202315 x 0.69
Class I recall Z-0111-2024, this FEI as the recalling firmSep 13, 202315 x 0.69
Class I recall Z-0915-2020, this FEI as the recalling firmDec 12, 201915 x 0.253.8
Class II recall Z-1750-2015, this FEI as the recalling firmMay 5, 201510 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
ResMed Ltd.
Location
BELLA VISTA New South Wales (AU)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.