CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
Provox Life Night HME recalled by Atos Medical AB
Atos Medical AB is recalling Provox Life Night HME, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1548-2021
- FDA event ID
- 87635
- Recalling firm
- Atos Medical AB, Horby
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2021
- FDA classified
- 10 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Mar 2021 | Recall initiated by company | |
| 10 May 2021 | Classified by FDA | +42 days |
| 19 May 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Product as listed by the FDA
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Where it was distributed
US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Nationwide ArizonaCaliforniaConnecticutIdahoIllinoisMichiganMinnesotaNorth CarolinaNew JerseyNew MexicoNew YorkOhioOklahomaPennsylvaniaSouth CarolinaVirginiaWisconsin
Questions about this recall
Why was it recalled?
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Which lots are affected?
Lot Numbers: 2012158 and 2012124
Where was it sold?
US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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