RegWardenFDA facility compliance records
Company

Vortex Surgical, Inc.

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

Recalls by year

FDA actions on record by year2023: 1 recalls; 2025: 2 recalls201720182019202020212022120232024220252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-12-16
    There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
  • Class IIOngoing2025-11-19
    Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
  • Class IITerminated2023-12-18
    Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

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. “Vortex Surgical, Inc. — 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-10052162-vortex-surgical-inc/

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