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Terminated

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

FDA Recall Z-0354-2020 · Posted None

Recalling FirmMonarch Medical Technologies
Recall StatusTerminated
Product CodeNDC
Date Initiated2019-10-01
Date Terminated2026-02-10
Product Quantity6 units

Reason for Recall

Product was distributed prior to approval or clearance from FDA.

Firm Action

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.

Root Cause

Software change control

Distribution Pattern

SC, IL IN, CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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