SPS-1 — Class II medical device recall Z-1111-2017
Terminated recall by Organ Recovery Systems, Inc., reported 2017-02-08, distributed nationwide. Organ preservation fluid recalled due to potential for bacterial contamination.
| Recall number | Z-1111-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organ Recovery Systems, Inc., Itasca, IL, United States |
| Recall initiated | 2016-12-14 |
| Classified | 2017-01-27 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2019-08-14 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination |
| Lot numbers | PBR-0060-386, PBR-0060-392, PBR-0074-330, PBR-0074-337 |
| Expiration dates | 2018-06-22, 2018-07-13 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1111-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.