Monarch Medical Technologies Recalls EndoTool SubQ Software Versions
Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries are mentioned in the source text.
Plain-English summary
Monarch Medical Technologies is recalling EndoTool SubQ software, specifically versions 1.7.1, 1.7.4, and 1.7.5. The recall was initiated because the product was distributed prior to approval or clearance from the U.S. Food and Drug Administration (FDA).
The recall affects six units of the software. Distribution was limited to South Carolina, Illinois, Indiana, and California. The agency has classified this recall as Class II.
Consumers and healthcare providers who have these specific versions of the EndoTool SubQ software should contact Monarch Medical Technologies for instructions on how to proceed. The source text does not provide specific contact details or instructions for remediation.
The recalled product
- Product
- EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- Manufacturer
- Monarch Medical Technologies
- Category
- Medical Device — Software
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- versions: v 1.7.1
- 1.7.4
- 1.7.5
Distribution
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