Monarch Medical Technologies recalls EndoTool SubQ versions 1.7.1, 1.7.4, and 1.7.5 due to distribution before FDA approval. Affected users should contact the company for details.
Product was distributed prior to approval or clearance from FDA.
Monarch Medical Technologies recalled specific versions of their EndoTool SubQ device because they were distributed before receiving FDA approval. This means the product may not be safe for use without proper regulatory clearance.
The product was distributed before FDA approval, which means it may not meet safety standards. Without proper regulatory clearance, there could be risks related to medical device safety and effectiveness.
Users of EndoTool SubQ versions 1.7.1, 1.7.4, and 1.7.5 are affected. Healthcare professionals who use these devices for medical procedures are most at risk.
Check the version number on your EndoTool SubQ device. Versions 1.7.1, 1.7.4, and 1.7.5 are affected. The product was distributed prior to FDA approval.
Look for the version number on your EndoTool SubQ device to confirm if it is affected (1.7.1, 1.7.4, or 1.7.5).
The product was distributed before FDA approval, which may mean it does not meet safety standards.
Contact Monarch Medical Technologies to determine if your version is affected and follow their instructions.
The recall is due to distribution before FDA approval, but specific injury risks are not described in the official notice.
We’ve drafted a message you can send Monarch Medical Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2020 — Monarch Medical Technologies Monarch Medical Technologies Hello, I own a Monarch Medical Technologies that is covered by recall Z-0354-2020 from Monarch Medical Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
