FDA Medical Device Recalls (openFDA)
Monarch Medical Technologies: Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
- Recall number
- Z-1786-2019
- 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.
- Status
- Open, Classified
- Initiated
- 2019-05-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- Insulin dosing calculations were erroneously high.
- 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
- 83 downloads
- Distribution
- Nationwide and Dubai
- Lot, serial or model codes
- Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
- 510(k) numbers
- ["K132547"]
- PMA numbers
- not on file
- Product code
- NDC
- Firm FEI
- 3009864844
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28