Class II — Potential Health Hazard

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

Beacon EUS Access System Preloaded Access 90degree Needle sterile Recalled by Covidien Llc Due to This voluntary recall is being conducted following three...

Date: June 26, 2020
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

Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

Quantity: 375 units

Why Was This Recalled?

This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

Where Was This Sold?

world wide distribution

About Covidien Llc

Covidien Llc has 59 total recalls tracked by RecallDetector.

Related Recalls

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