Welch Allyn ELI 380 Electrocardiograph: Wireless Disconnection Risk
Welch Allyn recalls ELI 380 electrocardiographs due to potential wireless disconnection from access points, which may disrupt medical monitoring. Affected units have specific part numbers listed in the recall notice.
Lower-risk recall
The radio within the device can become disassociated with the wireless access point.
Contact the company
What happened, in plain English
Welch Allyn is recalling ELI 380 electrocardiographs because the wireless radio can become disconnected from the access point, potentially disrupting medical monitoring. This could affect healthcare providers using the device for patient heart monitoring. Read more at govinfonow.com/recall/63937-welch-allyn-eli-380-electrocardiograph-wireless-disconnection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63937-welch-allyn-eli-380-electrocardiograph-wireless-disconnection-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0553-2021
Cite this page
“Welch Allyn ELI 380 Electrocardiograph: Wireless Disconnection Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63937-welch-allyn-eli-380-electrocardiograph-wireless-disconnection-risk. Based on FDA recall #Z-0553-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2021%22&limit=1).
Why it’s dangerous
The device's wireless radio may become disassociated from the access point during use, which could cause interruptions in the electrocardiograph's monitoring function. This might lead to incomplete or inaccurate patient heart data readings during medical procedures.
Who’s affected
Healthcare professionals using the ELI 380 electrocardiograph for patient monitoring are most at risk. The recall affects specific models sold with particular part numbers.
How to tell if you have this one
Check for the ELI 380 electrocardiograph with part numbers listed in the recall notice, such as ELI380-ABS12 (00732094265545) or ELI380-ACX12 (00732094265439). The device is intended for high-performance medical monitoring.
- Brand
Welch Allyn- Category
Medical device
What to do — step by step
Check Device Part Number
Look for the part number on the device label, such as ELI380-ABS12 or ELI380-ACX12.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.7 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-0553-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0553-2021 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.