Lead diagnostic electrocardiograph under the following device names:… — Class II medical device recall Z-1810-2020
Terminated recall by WELCH ALLYN, INC/MORTARA, reported 2020-05-06, distributed nationwide. Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medi
| Recall number | Z-1810-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WELCH ALLYN, INC/MORTARA, Milwaukee, WI, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2026-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 78,521 units |
| Model numbers | ELI10-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI280-XXX-XXXXX, ELI350-XXX-XXXXX, ELI380-XYYZZ |
Product
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.
Reason for recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1810-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.