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WESTMED, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
5580 S NOGALES HWY, TUCSON, AZ, 85706
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1000374126
DUNS Number
092673953

Catalogue (1289)

Page 26 of 26
DeviceModel / ReferenceRegistriesClassStatus
Disposable Anesthesia Circuits 9009
FDA UDI
Class IIUnknown
Adult Comfort Soft Plus 0588
FDA UDI
Class IActive
Septal-H Pediatric Size CP-5510A
FDA UDI
Class IActive
Adult Dual Lumen Cannula w/4' Kink Resistant Tubing 0507
FDA UDI
Class IActive
Anesthesia Circuit Kit R-8270
FDA UDI
Class IIActive
Mini-HEART® 100614A
FDA UDI
Class IIActive
Hme 6219
FDA UDI
Class IIActive
Disposable Anesthesia Circuits 6887
FDA UDI
Class IIActive
Uni-Lim 72" Adult Coaxail Breathing Circuit 8034
FDA UDI
Class IActive
Pulset 3302-50
FDA UDI
Class IActive
Oxygen tubing 0068
FDA UDI
Class IUnknown
MR Patient Care Pediatric LoFlo CO2 with Cannulas (20) P183251
FDA UDI
Class IIActive
CO2/ O2 Pediatric Elongated Mask 0562P
FDA UDI
Class IIUnknown
Hyperinflation (AMBU) 900 000 601
FDA UDI
Class IIActive
NeoPod 9402
FDA UDI
Class IIUnknown
Comfort Soft Plus 1002346
FDA UDI
Class IActive
Adult Elongated Medium Concentration Mask, 8' 3102-E
FDA UDI
Class IActive
Pulset 3600-20
FDA UDI
Class IActive
Disposable Anesthesia Circuits CA3107
FDA UDI
Class IUnknown
A-Line 3300-21
FDA UDI
Class IActive
Hyperinflation (AMBU) 900 000 609
FDA UDI
Class IIActive
Disposable Anesthesia Circuit 9013
FDA UDI
Class IActive
25" Oxygen Tubing, Green, Bulk 0027B
FDA UDI
Class IActive
Anesthesia Circuits 8143
FDA UDI
Class IIActive
Oxygen Tubing, KROT, 25', Purple 0035
FDA UDI
Class IUnknown
Gas Sampling Line 0535
FDA UDI
Class IActive
Comfort Soft Plus 0870
FDA UDI
Class IIActive
Disposable Anesthesia Circuit 9662
FDA UDI
Class IIUnknown
Adult Expandable Circuit 9356
FDA UDI
Class IActive
Disposable anesthesia circuits 9119
FDA UDI
Class IActive
NeoPod 9409
FDA UDI
Class IIUnknown
Westmed, Inc.'s Blockaide Filter [21 Cfr 807.87(a)] K121382
FDA 510(k)
Class IIActive
Accuflow And Accuflux Elastomeric Infusion Pump K081905
FDA 510(k)
Class IIActive
Westmed Gas Sampling Cannula with O2 delivery K162343
FDA 510(k)
Class IIActive
Disposable Pressure Manometer (DPM) K143148
FDA 510(k)
Class IIActive
Pedi Co2 Easy K072220
FDA 510(k)
Class IIActive
Co2 Easy K070128
FDA 510(k)
Class IIActive
Westmed Pediatric & Adult Medium Concentration Oxygen Mask K953464
FDA 510(k)
Class IActive
Vibralung Acoustical Percussor K133057
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (26)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Sep 27, 2024Z-0263-2025—open, classified

Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

Nov 11, 2020Z-0746-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Nov 11, 2020Z-0743-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Nov 11, 2020Z-0741-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Nov 11, 2020Z-0742-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Nov 11, 2020Z-0744-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Nov 11, 2020Z-0745-2021—terminated

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Jan 15, 2019Z-2436-2020—terminated

A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

Jan 15, 2019Z-2434-2020—terminated

A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

Jan 15, 2019Z-2435-2020—terminated

A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

Jan 18, 2011Z-0104-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0108-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0101-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0100-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0097-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0106-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0109-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0098-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0096-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0105-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0107-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0102-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0103-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jan 18, 2011Z-0099-2013—terminated

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Jun 22, 2010Z-2333-2010—terminated

This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.

Jun 22, 2010Z-2332-2010—terminated

This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.