Monarch Medical Technologies recalls EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- Recall date
- October 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0354-2020
- FDA classification
- Class II
- Brand / firm
- Monarch Medical Technologies
- Sold / distributed
- SC, IL IN, CA
Why it was recalled
Product was distributed prior to approval or clearance from FDA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
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