RegWardenFDA facility compliance records
Facility

Whele LLC

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

Activity by year

FDA actions on record by year2022: 1 recalls, 1 inspections; 2023: 1 inspections201720182019202020212202212023202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Scissors, General, Surgical
    Product code LRW (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

  • Class IOngoing2022-10-24
    The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

FDA inspections (2)

  • VAI2023-07-18
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2022-06-06
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “Whele LLC (FEI 3016774562) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016774562-whele-llc/

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