Sorin Group Recalls STOCKERT Heater-Cooler System 3T Due to Hydrogen Peroxide Risk
Sorin Group recalls STOCKERT Heater-Cooler System 3T models with potential hydrogen peroxide diffusion risk. Affected units have specific serial numbers and item numbers. Contact for remedy details.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Sorin Group recalls certain STOCKERT Heater-Cooler System 3T medical devices because plastic parts may let hydrogen peroxide leak into blood. This could cause harm during surgery if the device isn't properly maintained. Read more at govinfonow.com/recall/73480-sorin-group-recalls-stockert-heater-cooler-system-3t-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/73480-sorin-group-recalls-stockert-heater-cooler-system-3t-due-to · Updated September 21, 2026 · FDA enforcement record: FDA #Z-2775-2017
Cite this page
“Sorin Group Recalls STOCKERT Heater-Cooler System 3T Due to Hydrogen Peroxide Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73480-sorin-group-recalls-stockert-heater-cooler-system-3t-due-to. Based on FDA recall #Z-2775-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2775-2017%22&limit=1).
Why it’s dangerous
The plastic heat exchanger fibers in certain units may separate the blood and water compartments. This allows hydrogen peroxide to diffuse into the blood in amounts that exceed safe levels, potentially causing harm during surgery.
Who’s affected
Healthcare providers using the STOCKERT Heater-Cooler System 3T for medical procedures are most at risk. Patients undergoing surgery with this device could be affected if the hydrogen peroxide leaks.
How to tell if you have this one
Check for the item number 16-02-85 and serial numbers between 16S10958 and 16S16847 on the device. The product was sold with 120V/60 Hz power specifications.
- Brand
Sorin Group- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
"Domestic: 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. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2771-2017 | STOCKERT Heater-Cooler System 3T, 230 V; Item No. 16-02-83; Serial No. 16S11455-16S16509 | 7,546 units total |
| Z-2772-2017 | STOCKERT Heater-Cooler System 3T, 240V/60 Hz; Item No. 16-02-81; Serial No. 16S10743-16S11708 | 7,546 units |
| Z-2773-2017 | STOCKERT Heater-Cooler System 3T, 208V/60 Hz; Item No. 16-02-82; Serial No. 16S10772-16S16840 | 7,546 units |
| Z-2774-2017 | STOCKERT Heater-Cooler System 3T, 127V/60 Hz; Item No. 16-02-83; Serial No. 16S11455-16S16509 | 7,546 units |
| Z-2775-2017 | STOCKERT Heater-Cooler System 3T, 120V/60 Hz; Item No. 16-02-85; Serial No. 16S10958-16S16847 | 7,546 units |
| Z-2776-2017 | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz; Item No. 16-02-85; Serial No. 16S10958-16S16847 | 7,546 units |
What to do — step by step
Check Device Details
Verify the item number (16-02-85) and serial number (16S10958-16S16847) on the device.
Where it went and when
Where it was distributed
Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “"Domestic: 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. Foreign: AL, AE, AR, AT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 6.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2775-2017 (June 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2775-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.