Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lead diagnostic electrocardiograph under the following device names: ELI 10 Recalled by WELCH ALLYN, INC/MORTARA Due to Impacted Welch Allyn products may not meet the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact WELCH ALLYN, INC/MORTARA directly.
Affected Products
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
Quantity: 78,521 units total
Why Was This Recalled?
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About WELCH ALLYN, INC/MORTARA
WELCH ALLYN, INC/MORTARA has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report