CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report
Lead diagnostic electrocardiograph under the following recalled
Welch Allyn Inc/Mortara is recalling Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI, distributed nationwide in the US. The recall was initiated on 18 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1810-2020
- FDA event ID
- 85297
- Recalling firm
- Welch Allyn Inc/Mortara, Milwaukee, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2020
- FDA classified
- 29 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 18 Mar 2020 | Recall initiated by company | |
| 29 Apr 2020 | Classified by FDA | +42 days |
| 6 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Which lots are affected?
Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX.
Where was it sold?
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 85297This product is part of a recall event; the main page for the event is Pat Cbl 10wire Leadform XL Aha Snap recalled by Welch Allyn, Inc/mortara.
More recalls from Welch Allyn Inc/Mortara
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ELI, Burdick and McKesson brand 280 Resting recalledMcKesson | Welch Allyn Inc Mortara | Device Malfunction | Nationwide |
| Device | CLASS II | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory recalled | Welch Allyn Inc Mortara | Device Malfunction | Nationwide |
| Device | CLASS II | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory recalled | Welch Allyn Inc Mortara | Device Malfunction | Nationwide |
| Device | CLASS II | AM12M Acquisition Module accessory recalled by Welch Allyn Inc Mortara | Welch Allyn Inc Mortara | Device Malfunction | Nationwide |
| Device | CLASS II | Surveyor S12/S19 Bedside Patient Monitor recalled | Welch Allyn Inc Mortara | Device Malfunction | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |