RegWardenFDA facility compliance records
Company

Stratasys Ltd

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

Recalls by year

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

Registered facilities (2)

Recalls & enforcement

  • Class IIICompleted2024-01-19
    Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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. “Stratasys Ltd — 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-10086646-stratasys-ltd/

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