Welch Allyn Life2000 Ventilator Recall: Low Gas Pressure Alarm Failure Risk
Baxter Healthcare recalls Welch Allyn Life2000 Ventilation Systems with specific carton codes and software versions due to potential failure to trigger low gas pressure alarms if gas source isn't connected before use.
Use caution until it’s fixed
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
Contact the company
What happened, in plain English
Baxter Healthcare is recalling Welch Allyn Life2000 Ventilation Systems with certain carton codes and software versions. These ventilators may fail to sound a low gas pressure alarm if the gas source isn't connected before starting therapy, which could lead to unsafe conditions during medical use. Read more at govinfonow.com/recall/54032-welch-allyn-life2000-ventilator-recall-low-gas-pressure-alarm-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/54032-welch-allyn-life2000-ventilator-recall-low-gas-pressure-alarm-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0046-2025
Cite this page
“Welch Allyn Life2000 Ventilator Recall: Low Gas Pressure Alarm Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54032-welch-allyn-life2000-ventilator-recall-low-gas-pressure-alarm-failure. Based on FDA recall #Z-0046-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0046-2025%22&limit=1).
Why it’s dangerous
The ventilator may not activate the low gas pressure alarm if the oxygen source (compressor, cylinder, or wall connection) isn't properly connected before starting therapy. This could result in insufficient oxygen delivery if the system fails to warn the user.
Who’s affected
Healthcare providers using Welch Allyn Life2000 Ventilators with specific carton codes and software versions are most at risk. Patients receiving ventilation therapy through these devices could be affected if the system fails to alert to low gas pressure.
How to tell if you have this one
Check for carton codes: BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT-20-0011, or RMS010118CP. Also look for software version 06.08.00.00 or UDI/DI numbers 00887761978089 or 00815410020537.
- Brand
Welch Allyn- Category
Medical device
What to do — step by step
Check Device Settings
Ensure the oxygen source (compressor, cylinder, or wall connection) is connected before starting therapy to prevent low gas pressure alarm failure.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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-0046-2025 (September 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0046-2025 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.