Draegar Infinity Acute Care System: Alarms May Not Activate
Draegar recalls Infinity Acute Care System monitoring solutions with catalog numbers MS18841, MS20401, etc. due to potential failure of pressure visual and audible alarms.
Use caution until it’s fixed
The invasive pressure visual and audible alarms may not activate.
Contact the company
What happened, in plain English
Draegar is recalling certain Infinity Acute Care System monitoring solutions because the alarms might not work properly. This could mean patients aren't alerted to critical changes in their condition, which is serious for healthcare settings. Read more at govinfonow.com/recall/71927-draegar-infinity-acute-care-system-alarms-may-not-activate.
Source Summary by GovInfoNow · govinfonow.com/recall/71927-draegar-infinity-acute-care-system-alarms-may-not-activate · Updated August 28, 2026 · FDA enforcement record: FDA #Z-1382-2018
Cite this page
“Draegar Infinity Acute Care System: Alarms May Not Activate.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71927-draegar-infinity-acute-care-system-alarms-may-not-activate. Based on FDA recall #Z-1382-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1382-2018%22&limit=1).
Why it’s dangerous
The monitoring system's pressure alarms may not activate, meaning critical patient conditions could go unnoticed. This is especially dangerous in healthcare settings where immediate response to life-threatening changes is needed.
Who’s affected
Healthcare professionals using the Infinity Acute Care System monitoring solutions with the listed catalog numbers are most at risk. Patients in hospitals or clinics relying on these devices could be affected.
How to tell if you have this one
Check the catalog number on the device label. The affected models include MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, and MS31818.
- Brand
Draegar- Category
Medical device
What to do — step by step
Check Device Label
Look for the catalog number on the device label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica,…” 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 terminated this recall 2.2 years 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.
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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-1382-2018 (February 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1382-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 28, 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.