RegWardenFDA facility compliance records
Company

WESTMED, INC.

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

Recalls by year

FDA actions on record by year2011: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2024: 1 recalls1’11’12’13’14’15’16’17’181’191’20’21’22’231’24’25’26
  • Recalls (4)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “WESTMED, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9006543-westmed-inc/

Not open yet

Alerts for WESTMED, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.