FDA Medical Device Recalls (openFDA)
Monarch Medical Technologies: EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- Recall number
- Z-0354-2020
- Recalling firm
- Monarch Medical Technologies
- Product
- EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- Status
- Terminated
- Initiated
- 2019-10-01
- Posted
- not on file
- Terminated
- 2026-02-10
- Reason
- Product was distributed prior to approval or clearance from FDA.
- Root cause
- Software change control
- 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.
- Quantity
- 6 units
- Distribution
- SC, IL IN, CA
- Lot, serial or model codes
- versions: v 1.7.1, 1.7.4, 1.7.5
- 510(k) numbers
- not on file
- 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