RegWardenFDA facility compliance records
Company

SPECTRA MEDICAL DEVICES, LLC

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

Recalls by year

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

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2026-07-06
    Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, …

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. “SPECTRA MEDICAL DEVICES, 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-9012618-spectra-medical-devices-llc/

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