RegWardenFDA facility compliance records
Facility

ARROWHEAD DE LLC

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

Activity by year

FDA actions on record by year2016: 1 inspections; 2022: 1 inspections; 2026: 1 recalls, 1 inspections12016201720182019202020211202220232024202522026
  • Recalls (1)
  • Inspections (3)

Devices registered here (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.

FDA inspections (3)

  • VAI2026-06-17
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2022-12-07
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-03-30
    No Action Indicated · Compliance: Devices

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.

Related

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. “ARROWHEAD DE LLC (FEI 3008817603) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008817603-arrowhead-de-llc/

Not open yet

Alerts for ARROWHEAD DE LLC

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.