Stockert Heater-Cooler 3T — Class II medical device recall Z-1186-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-03-23, distributed nationwide. On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Co
| Recall number | Z-1186-2016 |
|---|---|
| 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 | 2012-08-15 |
| Classified | 2016-03-17 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,125 units |
| Model numbers | 16-02-8, 16-02-81, 16-02-82, 16-02-85, H3T/240V/60HZ |
Product
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Reason for recall
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
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-1186-2016. 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.