Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Temperature Sensing 100% Silicone Foley Catheter Recalled by Degania Medical Devices Pvt. Ltd. Due to Inadequate incoming inspection practices were utilized on thermistor...

Date: March 17, 2020
Company: Degania Medical Devices Pvt. Ltd.
Status: Terminated
Source: FDA (Device)

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 Medical Devices Pvt. Ltd. directly.

Affected Products

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Quantity: 1578

Why Was This Recalled?

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Degania Medical Devices Pvt. Ltd.

Degania Medical Devices Pvt. Ltd. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report