Facility

ORGAN RECOVERY SYSTEMS, INC.

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

Key facts

2recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004068499
Establishment type	Manufacture Medical Device
Location	One Pierce Place Itasca, IL, US 60143
Registration status	Active · expires 2026
Parent company	Organ Recovery Systems, Inc. (owner-operator 9056483)
Brand names	SPS-1®, Static Preservation Solution

Activity by year

Recalls (2)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Set, Perfusion, Kidney, Disposable
Product code KDL (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5880

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.

FDA inspections (2)

NAI2018-10-16
No Action Indicated · Compliance: Devices
OAI2017-02-10
Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2017-04-20
Warning Letter (opens in a new tab) · Itasca Illinois

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Organ Recovery Systems, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ORGAN RECOVERY SYSTEMS, INC. (FEI 3004068499) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004068499-organ-recovery-systems-inc/

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