# FDA recall Z-1548-2021

> **Atos Medical AB** · Class II · device recall initiated 2021-03-29.

## Product

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

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-1548-2021
- **Recalling firm:** Atos Medical AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-29
- **Report date:** 2021-05-19
- **Termination date:** 2022-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horby, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2021

## Citation

> AI Analytics. FDA recall Z-1548-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1548-2021. Source: US FDA. Licensed CC0.

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