Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect
Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could cause unit failure, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling seven units of the Sarns TCM II Temperature Control Module. These devices are used to provide temperature-controlled water for blood heat exchangers in extracorporeal circuits and are indicated for controlling and monitoring patient temperature.
The recall was initiated after internal testing revealed that certain systems were released with incorrectly assembled heatsink assemblies. This defect could cause the units to fail. The affected units are identified by Catalog Number 4416 and Serial Numbers 4656, 4657, 4658, 4659, 4661, 4662, and 4663.
The affected products were distributed worldwide, including the United Arab Emirates, Hong Kong, and Thailand. The source text explicitly states that these units were not distributed in the USA. Users should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 7
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 (7)
- Catalog Number 4416 and Serial Numbers: 4656
- 4657
- 4658
- 4659
- 4661
- 4662
- and 4663.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12