Z-1786-2019Class II

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

Name: Z-1786-2019 Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version...
Creator: Monarch Medical Technologies
Published: 2019-05-03
License: https://open.fda.gov/license/

Monarch Medical Technologies / initiated 2019-05-03 / Open, Classified / root cause: software

FDA source

Monarch Medical Technologies began a recall of Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10 on 2019-05-03. FDA classified it as Class II and gives the reason as "Insulin dosing calculations were erroneously high". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1786-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-03
Posted: 2019-06-15
Recalling firm: Monarch Medical Technologies
Product: Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Product code: NDC Calculator, Drug Dose
Reason for recall: Insulin dosing calculations were erroneously high.
Root cause tag: software
FDA root cause: Software change control
Action: The firm notified the consignees by email beginning on 05/03/2019. The notice alerted the consignee of the problem and provided an educational brief and a tip card to provide to the staff to remind them to always use clinical judgement in following EndoTool IV dose recommendations.
Quantity in commerce: 83 downloads
Distribution: Nationwide and Dubai
Product codes and lots: Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1786-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15

Product code NDC

K132547Class IIEndo Tool Glucose Management System (Egms)Monarch Medical Technologies / cleared 2014-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)