Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Temperature Sensor Catheter 10FR Recalled by Degania Silicone, Ltd. Due to The catheters are suspected to contain defective sensors;...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Degania Silicone, Ltd. directly.
Affected Products
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Quantity: 475
Why Was This Recalled?
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Degania Silicone, Ltd.
Degania Silicone, Ltd. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report