Monarch EndoTool IV insulin dosing error recall

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Contact the company & request your remedy

Recalling firmMonarch Medical Technologies2137 South Blvd Ste 300, N/A · Charlotte, NC 28203-5189

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Monarch Medical Technologies is recalling specific versions of their EndoTool IV insulin pump software because it calculates insulin doses too high, which could lead to overdose. This affects users who have the listed software versions and may need to update to a safer version.

Why it’s dangerous

The software versions calculate insulin doses higher than intended, which could lead to an overdose if the user is not aware of the error. This risk is specific to the software versions mentioned and not present in other versions.

Who’s affected

People using Monarch EndoTool IV insulin pumps with the recalled software versions are affected. Those with diabetes who rely on this device for insulin delivery are most at risk.

How to tell if you have this one

Check your EndoTool IV software version in the device settings. The affected versions are 1.8, 1.8.5 and higher, 1.9, and 1.10.

Brand
Monarch Medical Technologies
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version in your EndoTool IV device settings to confirm if it's one of the recalled versions.
Update Software
Update to a newer software version that is not listed in the recall to avoid the dosing error.

✎ GovInfoNow

Questions people ask

Do I need to stop using my EndoTool IV immediately?

No, but you should check your software version and update to a newer version if needed.

What versions of EndoTool IV are affected?

Versions 1.8, 1.8.5 and higher, 1.9, and 1.10.

Is there a risk of serious injury from this error?

The recall states the dosing calculations could be too high, but it does not specify a risk of serious injury in normal use.

Take action

Contact Monarch Medical Technologies

We’ve drafted a message you can send Monarch Medical Technologies to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1786-2019 — Monarch Medical Technologies Monarch Medical Technologies

Hello,

I own a Monarch Medical Technologies that is covered by recall Z-1786-2019 from Monarch Medical Technologies.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1786-2019 (May 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1786-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Monarch Medical Technologies recalls Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

Lower-risk recall