AmFab Co., LLC
3 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (3)
Devices registered here (1)
- Chair And Table, MedicalProduct code KMN (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6140
Recalls & enforcement
- Class IOngoing2025-04-11Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- Class IIOngoing2024-06-14The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
- Class IITerminated2016-02-17Tip 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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