RegWardenFDA facility compliance records
Facility

AmFab Co., LLC

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2024: 1 recalls; 2025: 1 recalls12016201720182019202020212022202312024120252026
  • Recalls (3)

Devices registered here (1)

Recalls & enforcement

  • Class IOngoing2025-04-11
    Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
  • Class IIOngoing2024-06-14
    The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
  • Class IITerminated2016-02-17
    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

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. “AmFab Co., LLC (FEI 1831748) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1831748-amfab-co-llc/

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