Puritan Bennett 980
35B
Lower-risk recall
In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,
Contact the company
What happened, in plain English
35B Read more at govinfonow.com/recall/64081-35b.
Source Summary by GovInfoNow · govinfonow.com/recall/64081-35b · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0425-2021
Cite this page
“Puritan Bennett 980.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64081-35b. Based on FDA recall #Z-0425-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0425-2021%22&limit=1).
Why it’s dangerous
low_ri sk
Who’s affected
all
How to tell if you have this one
35B
- Brand
35B- Product
Puritan Bennett 980 (PB980) Ventilator Series- Category
Medical device
What to do — step by step
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Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Argentina, Bolivia, Brazil, Cayman Islands, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0425-2021 (October 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0425-2021 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.