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Use caution Medical device recall · FDA · Published December 20, 2021

Vyaire Bellavista 1000 Ventilators May Stop Breathing Support

Vyaire Medical recalls Bellavista 1000 and 1000e ventilators with specific serial numbers due to potential breathing support failure. Affected units may need repair or replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0622-2022Medical deviceVyaire Medical ›
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Contact the company

Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420
✎ GovInfoNow plain-language explainer

Vyaire Medical is recalling Bellavista 1000 and 1000e ventilators with certain serial numbers because they could stop providing breathing support under specific conditions. This is serious for patients who rely on these ventilators for life support. Read more at govinfonow.com/recall/61416-vyaire-bellavista-1000-ventilators-may-stop-breathing-support.

Source Summary by GovInfoNow · govinfonow.com/recall/61416-vyaire-bellavista-1000-ventilators-may-stop-breathing-support · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0622-2022

Cite this page

“Vyaire Bellavista 1000 Ventilators May Stop Breathing Support.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61416-vyaire-bellavista-1000-ventilators-may-stop-breathing-support. Based on FDA recall #Z-0622-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2022%22&limit=1).

The FDA announced on Dec. 20, 2021, that Vyaire Medical is recalling bellavista 1000 and bellavista 1000e ventilators due to a potential cessation in ventilation. The agency classified the recall as Class I.

How to tell if you have it

  • bellavista 1000 ventilator, Catalog #301.100.030
  • bellavista 1000e ventilator, Catalog #301.100.130
  • Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers
  • UDI 07640149381115 (bellavista 1000 ventilator)
  • UDI 07640149388879 (bellavista 1000e ventilator)

The hazard

The recall addresses the potential for ventilation to cease under specific conditions. The bellavista 1000/1000e ventilators are intended to provide positive pressure ventilatory support to adult, pediatric, and optionally infant and neonatal patients.

Context

GovInfoNow's records show Vyaire Medical has had 9 other recalls on record since July 18, 2017. Other recent recalls of similar products include AirLife Infant Heated Wire Circuit Recall (April 10, 2025), Vyaire AirLife Resuscitator Recall (Jan. 10, 2024), and Vyaire Flexible Patient Circuit 3100A (Oct. 27, 2023). Other recent recalls of similar products include Ventec V+Pro Ventilator Recall (March 25, 2026), Philips Respironics Trilogy EV300 Ventilator Software Update Risk (March 2, 2026), and ResMed Astral Ventilators Recall (June 25, 2026).

How to tell if you have this one

Check for the model name 'Bellavista 1000' or 'Bellavista 1000e' with serial numbers starting with 07640149381115 or 07640149388879. These units were sold with hardware generation G6 and software version V6.0.1600.0 or higher.

  • Brand
    Vyaire Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Look for serial numbers starting with 07640149381115 (Bellavista 1000) or 07640149388879 (Bellavista 1000e).

  2. Contact Manufacturer

    Reach out to Vyaire Medical for guidance on next steps if you have the recalled ventilators.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 27 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including Puerto Rico and the countries of Argentina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Dec 20, 202112. FDA classified it Class I: Feb 16, 202223. Published in FDA’s Enforcement Report: Feb 23, 202234. FDA terminated the recall: Aug 28, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-0622-2022 (December 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0622-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA