STOCKERT Heater-Cooler System 3T — Class II medical device recall Z-2776-2017
Terminated recall by Sorin Group USA, Inc., reported 2017-08-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenato
| Recall number | Z-2776-2017 |
|---|---|
| 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 | 2017-06-30 |
| Classified | 2017-07-27 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2023-10-10 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 7,546 units |
| Serial numbers | 16S10958-16S16847 |
| Model numbers | 16-02-85 |
Product
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Reason for recall
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
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-2776-2017. 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.