Westmed, Inc.
United StatesFDA applicant, unverified FDA FEI 1000374126
- Devices
- 1,304
- Registrations
- FDA
- FDA recalls
- 261 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Westmed, Inc. makes
WestMed, Inc. manufactures single-use and reusable respiratory and anaesthesia devices, including breathing circuits for anaesthesia and ventilators, heat/moisture exchangers, nasal oxygen cannulas (with and without CO₂ sampling), nebulizing delivery sets, arterial blood sampling kits, and oxygen administration tubing. Their portfolio also covers infant resuscitation circuits and aerosol drug delivery systems.
The company’s products are regulated under FDA’s Class I and Class II device classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. WestMed, Inc. is based in the United States.
Catalogue
Search and filter all 1,304 devicesShowing 1-50 of 1,304
Company details
- FDA FEI number
- 1000374126
- DUNS number
- 092673953
- Address
- 5580 S NOGALES HWY, TUCSON, AZ, 85706
FDA recalls
FDA recall records list 26 recalls initiated by WESTMED, INC., the earliest on 2010-06-22 and the most recent on 2024-09-27. By recorded status: 1 ongoing and 25 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 3
- 2020 6
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 27 Sep 2024 Z-0263-2025 Class II Ongoing 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.
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- 27 Sep 2024 Z-0263-2025 Class II Ongoing 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.
2020
- 11 Nov 2020 Z-0741-2021 Class II 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.
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- 11 Nov 2020 Z-0742-2021 Class II 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.
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- 11 Nov 2020 Z-0743-2021 Class II 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.
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- 11 Nov 2020 Z-0744-2021 Class II 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.
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- 11 Nov 2020 Z-0745-2021 Class II 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.
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- 11 Nov 2020 Z-0746-2021 Class II 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.
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- 11 Nov 2020 Z-0741-2021 Class II 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.
2019
- 15 Jan 2019 Z-2434-2020 Class II 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.
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- 15 Jan 2019 Z-2435-2020 Class II 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.
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- 15 Jan 2019 Z-2436-2020 Class II 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.
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- 15 Jan 2019 Z-2434-2020 Class II 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.
Show the 25 most recent of 26 recalls
2011
- 18 Jan 2011 Z-0096-2013 Class II 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.
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- 18 Jan 2011 Z-0097-2013 Class II 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.
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- 18 Jan 2011 Z-0098-2013 Class II 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.
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- 18 Jan 2011 Z-0099-2013 Class II 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.
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- 18 Jan 2011 Z-0100-2013 Class II 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.
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- 18 Jan 2011 Z-0101-2013 Class II 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.
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- 18 Jan 2011 Z-0102-2013 Class II 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.
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- 18 Jan 2011 Z-0103-2013 Class II 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.
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- 18 Jan 2011 Z-0104-2013 Class II 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.
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- 18 Jan 2011 Z-0105-2013 Class II 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.
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- 18 Jan 2011 Z-0106-2013 Class II 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.
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- 18 Jan 2011 Z-0107-2013 Class II 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.
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- 18 Jan 2011 Z-0108-2013 Class II 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.
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- 18 Jan 2011 Z-0109-2013 Class II 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.
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- 18 Jan 2011 Z-0096-2013 Class II 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.
2010
- 22 Jun 2010 Z-2332-2010 Unclassified (pre-2012) 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.
Frequently asked questions
How many devices does WESTMED, INC. have in the registry?
The registry currently lists 1304 devices for WESTMED, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list WESTMED, INC.'s devices?
Among its 50 most recently registered devices, WESTMED, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do WESTMED, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for WESTMED, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for WESTMED, INC.?
FDA recall records list 26 recalls initiated by WESTMED, INC., the most recent initiated on 27 Sep 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from WESTMED, INC. in the registry?
The most recently registered devices listed for WESTMED, INC. include AMBU Hyperinflation System 900 000 614, AMBU Hyperinflation System 900 000 628, AMBU Hyperinflation System 900 000 617 and AMBU Hyperinflation System 900 000 604.