Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection
Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 classified as FDA Class II. The hazard is an intermittent connection causing false alarms, which is a functional defect without reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 100 units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 (Catalog Number 5773). The product is intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Internal testing at the supplier revealed that a crimped wire was placed into the air bubble detector (ABD) sensor connector backwards. This error prevents the crimped wire from locking into the mating wire connector, resulting in an intermittent connection. This defect may lead to false air bubble alarms.
The affected units were distributed worldwide and nationwide in the US. The recall covers specific serial numbers listed in the agency record. Users should stop using the affected sensors and contact the manufacturer for instructions on replacement or repair.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 100
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)
- UDI: 00886799000038
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 RX15 Oxygenator units recalled due to improper thermistor bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · false alarm
See all →- ModerateDialysis control units recalled over false blood leak detection alarms
FDA (Devices) · 2025-09-03
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- SevereInfusomat Space Infusion Pump Recall Due to Sensor Malfunction
FDA (Devices) · 2024-09-18
- HighBedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
FDA (Devices) · 2024-06-12
Similar recalls
- HighTerumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions
FDA (Devices) · 2012-07-25
- HighTerumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions
FDA (Devices) · 2012-07-25
- HighTerumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
FDA (Devices) · 2012-07-25
- HighTerumo Advanced Perfusion System 1 Recall for Module Malfunctions
FDA (Devices) · 2012-08-15
- HighTerumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
FDA (Devices) · 2012-07-25
- HighTerumo Advanced Perfusion System 1 recalled for module malfunctions
FDA (Devices) · 2012-08-15