Facility

WESTMED, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

1inspections · worst VAI

—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)	1000374126
Establishment type	Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	5580 S NOGALES HWY TUCSON, AZ, US 85706
Registration status	Active · expires 2026
Parent company	WESTMED, INC. (owner-operator 9006543)

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Mouthpiece, Breathing
Product code BYP (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5620

Recalls & enforcement

Class IIOngoing2024-09-27
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.
Class IITerminated2020-11-11
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.
Class IITerminated2019-01-15
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.
Class IITerminated2011-01-18
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

FDA inspections (1)

VAI2019-12-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by WESTMED, INC.

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. “WESTMED, INC. (FEI 1000374126) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000374126-westmed-inc/

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