Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 8, 2017
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Organ preservation fluid recalled due to potential for bacterial contamination.
The recall
Organ Recovery Systems, Inc. issued this moderate-severity FDA Devices recall — Organ preservation fluid recalled due to potential for bacterial contamination..
- Moderate
- severity level
- Class II
- classification
- February 8, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1111-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1111-2017) was formally reported on February 8, 2017, with the manufacturer initiating the action on December 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Organ Recovery Systems, Inc. is listed as the recalling firm, operating out of Itasca, IL. Federal records list the affected scope as 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags).
The documented reason for this recall is: Organ preservation fluid recalled due to potential for bacterial contamination. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
Related Recalls
6
6 from same agency
Product description
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Reason for recall
Organ preservation fluid recalled due to potential for bacterial contamination.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1111-2017 |
| Date reported | February 8, 2017 |
| Date initiated | December 14, 2016 |
| Recalling firm | Organ Recovery Systems, Inc. |
| Firm location | Itasca, IL |
| Affected scope | 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags) |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143. Recalled by Organ Recovery Systems, Inc.. Units affected: 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags).
Why was this product recalled? ▼
Organ preservation fluid recalled due to potential for bacterial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1111-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1111-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 8, 2017.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).