Class II — Potential Health Hazard

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

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal Recalled by Bien-Air Surgery Sa Due to The magnet located inside the foot pedal may...

Date: September 11, 2020
Company: Bien-Air Surgery Sa
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 Bien-Air Surgery Sa directly.

Affected Products

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

Quantity: N/A

Why Was This Recalled?

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bien-Air Surgery Sa

Bien-Air Surgery Sa has 5 total recalls tracked by RecallDetector.

Related Recalls

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