Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Organ Recovery Systems with 4 510(k) clearances, 2 device recalls and 1 warning letter. The most recent is a device recall dated Jan 30, 2020: LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Us….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 30, 2020 | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Class II · Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to mainta | Device recalls |
| Nov 28, 2018 | Warning letter: UnspecifiedCDRH | Warning letters |
| Dec 14, 2016 | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143Class II · Organ preservation fluid recalled due to potential for bacterial contamination. | Device recalls |
| Mar 11, 2010 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LK091656 · KDL | 510(k) clearances |
| Jul 31, 2003 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)K021362 · KDN | 510(k) clearances |
| Oct 21, 2002 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIIONK022391 · KDN | 510(k) clearances |
| Jan 25, 2002 | KPS-I, THE KIDNEY PERFUSION SOLUTIONK013575 · KDN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
