Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infinity FMS Pak Recalled by Alcon Research, LTD. Due to Reports of patient injury during use in procedures...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, LTD. directly.
Affected Products
Infinity FMS Pak
Quantity: 51,054 units
Why Was This Recalled?
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alcon Research, LTD.
Alcon Research, LTD. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report