FDAJune 21, 2018device
Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
degania siliconedegania
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCBazic Products Recalls Bazic Silicone Glue Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child Resistant Packaging and FHSA Labeling Requirements2026-01-29
- CPSCZippee Silicone Activity Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Imported by Mobi Games2025-11-13
- CPSCChews Life Recalls Silicone Rosary and Decade Teethers Due to Choking Hazard2025-03-13
- CPSCMelii Baby Silicone Spoons for Babies Recalled Due to Choking Hazard; Imported by Melii Baby2024-12-19
- CPSCSilicone Baby Toy Bear Activity Toys Recalled Due to Laceration Hazard; Manufactured by Konges Sløjd Denmark A/S2022-07-21
- CPSCMushie & Co Recalls FRIGG Silicone Pacifiers Due to Choking Hazard2022-01-19
- FDATemperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.2020-03-17
- FDATemperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.2020-03-17
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