Atos Medical AB: Medical Device Recall in 2021 - (Recall #: Z-1548-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 29, 2021

Date Posted: May 19, 2021

Recall Number: Z-1548-2021

Event ID: 87635

Reason for Recall:

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

Status: Terminated

Product Quantity: 225 boxes of 30 devices

Code Information:

Lot Numbers: 2012158 and 2012124

Distribution Pattern:

US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.

Voluntary or Mandated:

Voluntary: Firm initiated