RegWardenFDA facility compliance records
Company

Route 92 Medical

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

Recalls by year

FDA actions on record by year2024: 1 recalls20172018201920202021202220231202420252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IOngoing2024-03-08
    Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

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. “Route 92 Medical — 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-10054934-route-92-medical/

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