Class II — Potential Health Hazard

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

Provox Life Night HME Recalled by Atos Medical AB Due to Provox Life Night HME may be incorrectly inserted...

Date: March 29, 2021
Company: Atos Medical AB
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 Atos Medical AB directly.

Affected Products

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

Quantity: 225 boxes of 30 devices

Why Was This Recalled?

Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Atos Medical AB

Atos Medical AB has 1 total recall tracked by RecallDetector.

Related Recalls

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