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Sign in to claim this brandWESTMED, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5580 S NOGALES HWY, TUCSON, AZ, 85706
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000374126
- DUNS Number
- 092673953
Catalogue (1289)
Page 26 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Anesthesia Circuits | 9009 | FDA UDI | Class II | Unknown |
| Adult Comfort Soft Plus | 0588 | FDA UDI | Class I | Active |
| Septal-H Pediatric Size | CP-5510A | FDA UDI | Class I | Active |
| Adult Dual Lumen Cannula w/4' Kink Resistant Tubing | 0507 | FDA UDI | Class I | Active |
| Anesthesia Circuit Kit | R-8270 | FDA UDI | Class II | Active |
| Mini-HEART® | 100614A | FDA UDI | Class II | Active |
| Hme | 6219 | FDA UDI | Class II | Active |
| Disposable Anesthesia Circuits | 6887 | FDA UDI | Class II | Active |
| Uni-Lim 72" Adult Coaxail Breathing Circuit | 8034 | FDA UDI | Class I | Active |
| Pulset | 3302-50 | FDA UDI | Class I | Active |
| Oxygen tubing | 0068 | FDA UDI | Class I | Unknown |
| MR Patient Care Pediatric LoFlo CO2 with Cannulas (20) | P183251 | FDA UDI | Class II | Active |
| CO2/ O2 Pediatric Elongated Mask | 0562P | FDA UDI | Class II | Unknown |
| Hyperinflation (AMBU) | 900 000 601 | FDA UDI | Class II | Active |
| NeoPod | 9402 | FDA UDI | Class II | Unknown |
| Comfort Soft Plus | 1002346 | FDA UDI | Class I | Active |
| Adult Elongated Medium Concentration Mask, 8' | 3102-E | FDA UDI | Class I | Active |
| Pulset | 3600-20 | FDA UDI | Class I | Active |
| Disposable Anesthesia Circuits | CA3107 | FDA UDI | Class I | Unknown |
| A-Line | 3300-21 | FDA UDI | Class I | Active |
| Hyperinflation (AMBU) | 900 000 609 | FDA UDI | Class II | Active |
| Disposable Anesthesia Circuit | 9013 | FDA UDI | Class I | Active |
| 25" Oxygen Tubing, Green, Bulk | 0027B | FDA UDI | Class I | Active |
| Anesthesia Circuits | 8143 | FDA UDI | Class II | Active |
| Oxygen Tubing, KROT, 25', Purple | 0035 | FDA UDI | Class I | Unknown |
| Gas Sampling Line | 0535 | FDA UDI | Class I | Active |
| Comfort Soft Plus | 0870 | FDA UDI | Class II | Active |
| Disposable Anesthesia Circuit | 9662 | FDA UDI | Class II | Unknown |
| Adult Expandable Circuit | 9356 | FDA UDI | Class I | Active |
| Disposable anesthesia circuits | 9119 | FDA UDI | Class I | Active |
| NeoPod | 9409 | FDA UDI | Class II | Unknown |
| Westmed, Inc.'s Blockaide Filter [21 Cfr 807.87(a)] | K121382 | FDA 510(k) | Class II | Active |
| Accuflow And Accuflux Elastomeric Infusion Pump | K081905 | FDA 510(k) | Class II | Active |
| Westmed Gas Sampling Cannula with O2 delivery | K162343 | FDA 510(k) | Class II | Active |
| Disposable Pressure Manometer (DPM) | K143148 | FDA 510(k) | Class II | Active |
| Pedi Co2 Easy | K072220 | FDA 510(k) | Class II | Active |
| Co2 Easy | K070128 | FDA 510(k) | Class II | Active |
| Westmed Pediatric & Adult Medium Concentration Oxygen Mask | K953464 | FDA 510(k) | Class I | Active |
| Vibralung Acoustical Percussor | K133057 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 27, 2024 | Z-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, 2020 | Z-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, 2020 | Z-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, 2020 | Z-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, 2020 | Z-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, 2020 | Z-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, 2020 | Z-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, 2019 | Z-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, 2019 | Z-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, 2019 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2010 | Z-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, 2010 | Z-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. |