Monarch Medical Technologies EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Brand
Monarch Medical Technologies
Lot Codes / Batch Numbers
versions: v 1.7.1, 1.7.4, 1.7.5
Products Sold
versions: v 1.7.1, 1.7.4, 1.7.5
Monarch Medical Technologies is recalling EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) due to Product was distributed prior to approval or clearance from FDA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was distributed prior to approval or clearance from FDA.
Recommended Action
Per FDA guidance
The firm held meetings and emailed the consignees beginning on 09/27/2019 and followed with a letter. The notice stated that no medical decision should be based solely on the recommended guidance provided by the software program and requested the facility take additional precautions when following EndoTool SubQ 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 noticeDistribution
As reported by FDA
CA, IL, IN, SC
Page updated: Jan 10, 2026