Class II — Organ Recovery Systems, Inc.
| Recalling firm | Organ Recovery Systems, Inc. |
|---|---|
| Registered facility | ORGAN RECOVERY SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. |
| Product | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient. |
| Quantity | 2274 |
| Distribution | Distributed nationwide (32 states) and to Canada. |
| Initiated | 2020-01-30 |
| Classified | 2020-03-04 |
| Terminated | 2021-09-30 |
| Recall number | Z-1437-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Organ Recovery Systems, Inc. (Z-1437-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84880/
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