SmartRelease ESTR Onyx Blade Assembly (SKU 83030-1/6/6-CE) may unintentionally cut tissue before deployment. Affected units from specific lot numbers and dates require action to prevent injury.
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
SmartRelease ESTR Onyx Blade Assemblies (sold as SmartRelease Onyx) are being recalled because they might cut tissue before the user activates them. This could cause injury during medical procedures.
The blade may cut soft tissue before the user intentionally deploys it during surgery. This happens because the blade's release mechanism can activate prematurely under certain conditions, potentially causing injury to the patient's tissue.
Medical professionals using the SmartRelease ESTR system for endoscopic procedures are most at risk. Patients undergoing surgery with these blades could experience unintended tissue damage.
Check for SmartRelease Onyx Blade Assemblies with SKU numbers 83030-1 (single pack), 83030-6 (six pack), or 83306-CE (six pack OUS only). Affected units have specific lot numbers listed in the recall notice.
Identify your SmartRelease Onyx Blade Assembly by SKU numbers (83030-1, 83030-6, or 83030-6-CE) or lot numbers listed in the recall notice.
Reach out to MicroAire Surgical Instruments, LLC for guidance on next steps if you have an affected product.
The blades may unintentionally cut tissue before the user deploys them during surgery, which could cause injury to the patient.
SmartRelease Onyx Blade Assemblies with SKU numbers 83030-1 (single pack), 83030-6 (six pack), or 83030-6-CE (six pack OUS only).
Check for the specific SKU numbers or lot numbers listed in the recall notice.
We’ve drafted a message you can send SmartRelease to request your refund or repair — edit it as you like.
Subject: Recall Z-1975-2025 — SmartRelease SmartRelease Hello, I own a SmartRelease that is covered by recall Z-1975-2025 from SmartRelease. 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.
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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.
