Provox Life Night HME — Class II medical device recall Z-1548-2021
Terminated recall by Atos Medical AB, reported 2021-05-19, distributed nationwide. Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potenti
| Recall number | Z-1548-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atos Medical AB, Horby, Sweden |
| Recall initiated | 2021-03-29 |
| Classified | 2021-05-10 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2022-02-17 |
| Distributed | Nationwide (US) |
| Lot numbers | 2012124, 2012158 |
| Model numbers | 8262 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1548-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.