Z-1548-2021Class II

Provox Life Night HME, Catalogue Number 8262 -

Name: Z-1548-2021 Provox Life Night HME, Catalogue Number 8262 -
Creator: Atos Medical AB
Published: 2021-03-29
License: https://open.fda.gov/license/

Atos Medical AB / initiated 2021-03-29 / Terminated / root cause: design

FDA source

Atos Medical AB began a recall of Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma on 2021-03-29. FDA classified it as Class II and gives the reason as "Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1548-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Posted: 2021-05-10
Terminated: 2022-02-17
Recalling firm: Atos Medical AB
Product: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Root cause tag: design
FDA root cause: Device Design
Action: Atos Medical initiated the recall by telephone and email on 03/29/2021 to the medical facilities. The firm followed with a letter mailed (USPS) on 04/01/2021. The firm will begin contacting the patients the week of April 5, 2021 to confirm receipt of the letter, confirm understanding of the correct use, and answer any questions.
Quantity in commerce: 225 boxes of 30 devices
Distribution: US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Product codes and lots: Lot Numbers: 2012158 and 2012124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1548-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1548-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10

Product code BYD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)