Z-0354-2020Class II

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Name: Z-0354-2020 EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Creator: Monarch Medical Technologies
Published: 2019-10-01
License: https://open.fda.gov/license/

Monarch Medical Technologies / initiated 2019-10-01 / Terminated / root cause: software

FDA source

Monarch Medical Technologies began a recall of EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) on 2019-10-01. FDA classified it as Class II and gives the reason as "Product was distributed prior to approval or clearance from FDA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0354-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Posted: 2019-11-08
Terminated: 2026-02-10
Recalling firm: Monarch Medical Technologies
Product: EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Product code: NDC Calculator, Drug Dose
Reason for recall: Product was distributed prior to approval or clearance from FDA.
Root cause tag: software
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 in commerce: 6 units
Distribution: SC, IL IN, CA
Product codes and lots: versions: v 1.7.1, 1.7.4, 1.7.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0354-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0354-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-08

Product code NDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)