Class II — Potential Health Hazard

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

400mL Recalled by COVIDIEN LLC Due to The temperature sensor catheters may be defective in...

Date: July 11, 2018
Company: COVIDIEN LLC
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 COVIDIEN LLC directly.

Affected Products

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD

Quantity: 27515 total

Why Was This Recalled?

The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Where Was This Sold?

This product was distributed to 24 states: CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MO, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA

Affected (24 states)Not affected

About COVIDIEN LLC

COVIDIEN LLC has 22 total recalls tracked by RecallDetector.

Related Recalls

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