RegWardenFDA facility compliance records
Company

DYNAREX CORP.

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2016: 1 recalls; 2018: 1 recalls1’14’151’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-05-08
    The device is equipped with a dial that has an inaccurate flow rate indicator.
  • Class IITerminated2016-03-03
    Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
  • Class IITerminated2014-07-02
    "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

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. “DYNAREX CORP. — 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-2431014-dynarex-corp/

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