RegWardenFDA facility compliance records
Company

Organ Recovery Systems, Inc.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2020: 1 recalls1201620172018201912020202120222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2020-01-30
    Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
  • Class IITerminated2016-12-14
    Organ preservation fluid recalled due to potential for bacterial contamination.

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. “Organ Recovery Systems, 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-9056483-organ-recovery-systems-inc/

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