RegWardenFDA facility compliance records
Recall

Class II — Organ Recovery Systems, Inc.

Recalling firmOrgan Recovery Systems, Inc.
Registered facilityORGAN RECOVERY SYSTEMS, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonOrgan preservation fluid recalled due to potential for bacterial contamination.
ProductSPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Quantity4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
DistributionNationwide
Initiated2016-12-14
Classified2017-01-27
Terminated2019-08-14
Recall numberZ-1111-2017
InitiationVoluntary: 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-1111-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75978/

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