Class II — Potential Health Hazard

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

Medline Thermistor Foley Catheter 14 FR 5-10 ml Recalled by Degania Silicone, Ltd. Due to Temperature deviation did not meet release specifications

Date: December 2, 2019
Company: Degania Silicone, 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 Silicone, Ltd. directly.

Affected Products

Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

Quantity: 2080 units

Why Was This Recalled?

Temperature deviation did not meet release specifications

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Degania Silicone, Ltd.

Degania Silicone, Ltd. has 43 total recalls tracked by RecallDetector.

Related Recalls

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