Atos Medical Provox Life Night HME Recall: Risk of Stoma Blockage
Atos Medical recalls Provox Life Night HME heat and moisture exchangers (catalog 8262) due to potential stoma blockage from incorrect insertion. Affected units: lot numbers 2012158 and 2012124.
Use caution until it’s fixed
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Contact the company
What happened, in plain English
Atos Medical is recalling Provox Life Night HME single-use heat and moisture exchangers because they might block a patient's stoma if inserted incorrectly. This could cause breathing problems for people using tracheostomies. Read more at govinfonow.com/recall/62891-atos-medical-provox-life-night-hme-recall-risk-of-stoma.
Source Summary by GovInfoNow · govinfonow.com/recall/62891-atos-medical-provox-life-night-hme-recall-risk-of-stoma · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1548-2021
Cite this page
“Atos Medical Provox Life Night HME Recall: Risk of Stoma Blockage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62891-atos-medical-provox-life-night-hme-recall-risk-of-stoma. Based on FDA recall #Z-1548-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1548-2021%22&limit=1).
Why it’s dangerous
The device may be inserted sideways or forced through the adhesive coupling, which could block the stoma. This blockage might prevent proper breathing for patients with tracheostomies.
Who’s affected
Patients using tracheostomies with this specific product are most at risk. The recall affects only those with the listed lot numbers.
How to tell if you have this one
Check the lot number on the product label. Affected units have lot numbers 2012158 or 2012124. This product is a single-use heat and moisture exchanger for tracheostomy patients.
- Brand
Atos Medical- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for lot numbers 2012158 or 2012124 on the device label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Idaho, Illinois, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product immediately?
The recall does not require immediate discontinuation; check the lot number to see if your unit is affected.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1548-2021 (March 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1548-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.