Sorin Stockert Heater-Cooler System 3T — Class II medical device recall Z-1901-2018
Terminated recall by LivaNova USA, reported 2018-05-30, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Hea
| Recall number | Z-1901-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Arvada, CO, United States |
| Recall initiated | 2018-04-20 |
| Classified | 2018-05-18 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2025-02-05 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WY |
| Quantity | 2,408 |
| Reason classes | microbial contamination |
| Model numbers | 120, 16-02-81, 16-02-82, 16-02-85, 208, 240, V/60 |
Product
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
Reason for recall
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
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-1901-2018. 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.