Class II — Potential Health Hazard

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

EsoFLIP Recalled by Covidien, LLC Due to Due to saline conductivity issues, their is a...

Date: April 25, 2024
Company: Covidien, LLC
Status: Ongoing
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

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Quantity: N/A

Why Was This Recalled?

Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Covidien, LLC

Covidien, LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

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