Degania Silicone, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-2785-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Temperature sensing catheter 16FR, Catalogue Number 102201101663NU 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.

Product Classification:

Class II

Date Initiated: June 21, 2018

Date Posted: September 26, 2018

Recall Number: Z-2785-2018

Event ID: 80641

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1000

Code Information:

V17015147

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated