SagaTech Finger Sensor for Remmers Recorder Recalled for Premature Jacket Recession
SagaTech Electronics is recalling 152 Finger Sensors for Remmers Recorders because the outer jacket is receding prematurely from the black sensor.
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, and the source text describes a physical defect (jacket recession) without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or minor defects where harm has not been reported.
Plain-English summary
SagaTech Electronics, Inc. is recalling 152 units of the Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder). The product is used to gather heart rate and blood oxygen data during a sleep study. The recall involves 77 devices from lot 13367 and 75 devices from lot 13710, all with model number 1.1.
The recall is being issued because the outer jacket of the sensor is receding away from the black sensor prematurely. This defect may affect the integrity of the device during use.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Canada and Mexico. Consumers should stop using the recalled sensors and contact SagaTech Electronics for instructions on how to proceed.
The recalled product
- Product
- Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
- Manufacturer
- SagaTech Electronics, Inc.
- Hazard
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)
- Model: 1.1 Lot numbers: 13367 and 13710
Distribution
Distributed nationwide across the United States.
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