Sorin Stockert Heater-Cooler 3T — Class II medical device recall Z-2078-2015
Terminated recall by Sorin Group USA, Inc., reported 2015-07-22, distributed nationwide. Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfe
| Recall number | Z-2078-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2015-06-15 |
| Classified | 2015-07-15 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2018-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 283 |
| Serial numbers | 16S10772-16S15523 |
Product
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Reason for recall
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
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-2078-2015. 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.