RegWardenFDA facility compliance records
Company

QUANTA SYSTEM, S.P.A.

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2021: 1 recalls1’12’13’14’15’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2021-04-27
    Product sterility is potentially compromised.
  • Class IITerminated2012-11-07
    Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.

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. “QUANTA SYSTEM, S.P.A. — 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-9057522-quanta-system-s-p-a/

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