RegWardenFDA facility compliance records
Company

Arrowhead DE LLC

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

Recalls by year

FDA actions on record by year2026: 1 recalls20172018201920202021202220232024202512026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-06-23
    Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

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. “Arrowhead DE LLC — 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-10034076-arrowhead-de-llc/

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