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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Brand
Monarch Medical Technologies
Lot Codes / Batch Numbers
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Products Sold
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Monarch Medical Technologies is recalling Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 an due to Insulin dosing calculations were erroneously high.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Insulin dosing calculations were erroneously high.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026