Sorin Group Recalls Stöckert Heater Cooler System 3T for Disinfection Review
Sorin Group USA is recalling Stöckert Heater Cooler System 3T units to ensure strict adherence to disinfection and monitoring instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure to ensure adherence to existing instructions for use, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sorin Group USA, Inc. is recalling the Stöckert Heater Cooler System 3T, a medical device used with heart lung machines for extracorporeal perfusion. The recall involves specific item numbers 16 02 81, 16 02 82, and 16 02 85, covering units with 240V, 208V, and 120V power configurations.
The recall was initiated on August 1, 2014, when Sorin Group USA informed consignees to review their disinfection and monitoring practices. The firm requested that users strictly adhere to the instructions provided in the Instructions for Use (IFU) to ensure proper device operation and safety.
The affected units were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, and Trinidad and Tobago. A total of 1,618 units were distributed in the US and 129 units outside the US. All serial numbers are included in this recall. Users should review their current practices against the IFU and contact the manufacturer for further guidance.
The recalled product
- Product
- ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart
- Manufacturer
- Sorin Group USA, Inc.
- Category
- Medical Device — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · infection risk
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighMedline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration
FDA (Devices) · 2026-08-19
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29