Class II — Atos Medical AB
| Recalling firm | ATOS MEDICAL AB |
|---|---|
| Registered facility | ATOS MEDICAL AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. |
| Product | 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 |
| 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. |
| Initiated | 2021-03-29 |
| Classified | 2021-05-10 |
| Terminated | 2022-02-17 |
| Recall number | Z-1548-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atos Medical AB (Z-1548-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87635/
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